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Diagnostic Equipment

🏥 Medical Devices 6,554 recalls

BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323 BD Pyxis" CII Safe ES / 10885403512605 / 1116-00 BD Pyxis" Enterprise Server / 10885403518348 and 10885403520341 / 1115-00 BD Pyxis" CIISafe, V9.X, SGL IM, BIO, / 10885403512520 / 111-221 BD Pyxis" CIISafe, V7.X, DBL INTG MAIN, BIO, SOLID DO / N/A / 111-194 BD Pyxis" MedBank Tower / 10885403512568 / 169-29 BD Pyxis" CIISafe, V8.X Desktop PC, Bio / N/A / 107-245-01 Supply Server / N/A / N/A CCE Enterprise SW Site License (2-5) / N/A / N/A BD Pyxis" Logistics / N/A / 806 BD Pyxis" SupplyStation" V9 / N/A / 317 Security Module / N/A / 139698-01 Supply itParActive RF V11 / N/A / 138566-01 BD Knowledge Portal for Medication Technologies / N/A / 136607-01 STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-02 PRS STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-01 STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-02 PRS STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-01 BD Pyxis" CII Safe ES, Desktop PC / N/A / 1156-00 BD Pyxis" SupplyStation" Panel PC V11 / N/A / 1132-00 Pyxis" SupplyRoller V11 / N/A / 1127-00 Dell 640 Server / N/A / 1128-00 BD Pyxis" SupplyStation" System V11 / N/A / 1123-00 BD Pyxis" SupplyRoller V10 / N/A / 1101-00 BD Pyxis" SupplyStation" System V10 / **** / 347 BD Pyxis CII Safe,V9.X DESKTOP PC / **** / 107-252-01 BD Pyxis CII Safe,V7.X,DBL INTG MAIN,BIO,CLEAR DO 111-191 BD Pyxis CII Safe, V9.X, DBL IM, BIO, SLD DOORS / **** / 111-215 BD Care Coordination Engine (CCE) / **** / 134056-01 The Pyxis devices are automated medication dispensing cabinet that is intended to securely store and dispense medications to a qualified and authorized healthcare provider.

CareFusion 303

Class I - Dangerous

Antivirus software was not consistently installed on impacted devices during the implementation process.

May 8, 2025 Diagnostic Equipment Nationwide View Details →

Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.

Jun 12, 2025 Diagnostic Equipment Nationwide View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611000 5 SPUR II Adult Resuscitator, Pop-off open 40 ,w/PEEP Valve 20, Adult, Catalog Number: 524611001 6 SPUR II Adult Resuscitator w/PEEP Valve 20, Adult, Catalog Number: 524611011 7 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611031 8 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611047 9 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611051 10 SPUR II Pediatric Resuscitator w/10 O2 tube & Manometer, Catalog Number: 530200016 11 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212000 12 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212001 13 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213000 14 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213001 15 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213011 16 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530213030 17 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213031 18 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213048 19 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530214000 20 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613000 21 SPUR II Pediatric Resuscitator w/Manometer & PEEP Valve 20, Pediatric, Catalog Number: 530613031 22 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613071 23 SPUR II Pediatric Resuscitator w/PEEP Valve 20,Manometer & CO2 Detector, Pediatric, Catalog Number: 530613831 24 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530614017 25 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530614030 26 SPUR II Pediatric Resuscitator w/CO2 Detector, Pediatric, Catalog Number: 530614800 27 SPUR II Pediatric Resuscitator, INF& TOD W/Manometer, Pediatric, Catalog Number: 530615030 28 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530619031 29 SPUR II Pediatric Resuscitator w/Expiratory Filter, Manometer PEEP Valve, Pediatric, Catalog Number: 531600051 30 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613000 31 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613001 32 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613010 33 SPUR¿ II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613031 34 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613047 35 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:531613051 36 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531614026 37 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531638000 38 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611051E 39 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:530213000B The Ambu SPUR II Resuscitator is a single patient use resuscitator intended for pulmonary resus

Ambu

Class I - Dangerous

Potential for the manometer port being blocked rendering the manometer non-functional.

Jul 9, 2025 Diagnostic Equipment Nationwide View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

Jun 20, 2025 Diagnostic Equipment View Details →