VITROS 4600 Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
All Recalls
95,038 total recalls in our database
🏥 Medical Devices Class I - Dangerous
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
VITROS 350 Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
🏥 Medical Devices Class I - Dangerous
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Maxim Laser Projection Series
Gk Photonics
🏥 Medical Devices Class I - Dangerous
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
🏥 Medical Devices Class I - Dangerous
Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
🏥 Medical Devices Class I - Dangerous
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
VITROS 5600 Integrated System, clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Atom Laser Projection Series
Gk Photonics
🏥 Medical Devices Class I - Dangerous
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
Ingenuity Core Model # 728321, computed tomography x-ray system
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
Medical Components, Inc
🏥 Medical Devices Class I - Dangerous
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
🏥 Medical Devices Class I - Dangerous
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
Vereos PET/CT Model # 882446, computed tomography x-ray system
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
🏥 Medical Devices Class I - Dangerous
Lack of 510K clearance
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
Abbott Ireland Diagnostics Division
🏥 Medical Devices Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
Medline Industries
🏥 Medical Devices Class I - Dangerous
Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
IQon Spectral CT Model # 728332, computed tomography x-ray system
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied