The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
All Recalls
95,038 total recalls in our database
iCT, Model # 728306, 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
Potentially Biased Results using VITROS Chemistry Products GLU Slides
VITROS 250 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
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Comet Technologies Usa
🏥 Medical Devices Class I - Dangerous
Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only the movement of the door.
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.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
St Jude Medical
🏥 Medical Devices Class I - Dangerous
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Comet Technologies Usa
🏥 Medical Devices Class I - Dangerous
Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only the movement of the door.
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 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.
LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
🏥 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.
Ingenuity CT, Model # 728326, 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
UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Ad-Tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices. Further, Ad-Tech labeling does not include instructions for sterilizing anchor bolts.
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Potential for sterile packaging to be compromised
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Randox Laboratories, Limited
🏥 Medical Devices Class I - Dangerous
The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.