🏥 Medical Devices Class I - Dangerous
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
All Recalls
95,094 total recalls in our database
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
🏥 Medical Devices Class I - Dangerous
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
🏥 Medical Devices Class I - Dangerous
Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
🏥 Medical Devices Class I - Dangerous
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Roche Molecular Systems
🏥 Medical Devices Class I - Dangerous
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: LS MS PACK
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
TRACH PACK. Sterile Procedural Tray.
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
🏥 Medical Devices Class I - Dangerous
Two planers were found to be unusable during sawbones shoulder training.