Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
-
Class II · 1+ years ago
Philips CT systems labeled as the following: 1. CT 6000 recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
-
Class II · 1+ years ago
CooperVision, Inc. MyDay Toric, stenfilcon A) Contact Lens. Model/ recall: One lot manufactured with an invalid sterilization cycle
One lot manufactured with an invalid sterilization cycle.
-
Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD20 OR Table Product Codes recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
-
Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD10 Product Codes: 722010 recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
-
Class II · 1+ years ago
Philips CT systems labeled as the following: 1. Ingenuity CT Family recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
-
Class II · 1+ years ago
Philips CT systems labeled as the following: 1. Big Bore RT recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
-
Class II · 1+ years ago
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 recall: Due to a weld breakage between the pin and inserter holder of the Inserter
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
-
Class II · 1+ years ago
Philips CT systems labeled as the following: 1. IQon Spectral CT recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
-
Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura CV20 recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
-
Class II · 1+ years ago
Philips CT systems labeled as the following: 1. Brilliance iCT recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
-
Class II · 1+ years ago
Stryker Communications Chromophare Surgical Light System, REF: CH00000001 recall: Surgical lights have stress lines forming on the powder coating
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
-
Class I · 1+ years ago
Abiomed, Inc. Automated Impella Controller with the below brands and product codes recall: Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased…
-
Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD10 OR Table Product Codes recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
-
Class II · 1+ years ago
Maquet Cardiovascular, LLC Vasoview Hemopro 3 Endoscopic Vessel Harvesting System recall: Reports of out-of-box failures discovered during the limited launch phase
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the…
-
Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD20/15 OR Table recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
-
Class I · 1+ years ago
Medline medical convenience kits labeled as: 1. Adult Intubation Tray recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic…
-
Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD10/10 Product Codes: 722011 recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
-
Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD20/15 recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
-
Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD20 Biplane Product Codes recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
-
Class II · 1+ years ago
Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology recall: an app defect that occurs when the phone is set to a right-to-left language
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can…
-
Class II · 1+ years ago
Baxter Healthcare Corporation Baster Continu-Flo Solution Set, Non-Vented recall: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer…
-
Class II · 1+ years ago
Abbott Point Of Care Inc. i-STAT EG7+ cartridge. List Number: 03P76-25 recall: Lack of a 510(k) premarket clearance for the i-STAT CG8+
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium…
-
Class II · 1+ years ago
Maquet Cardiovascular, LLC Heartstring III Proximal Seal System recall: Three failure modes have been identified: failure of the Heartstring Seal
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and…
-
Class II · 1+ years ago
Exactech Equinoxe recall: Reverse Shoulder humeral liners have an articular surface position outside
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.