🏥 Medical Devices Class I - Dangerous
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
All Recalls
95,083 total recalls in our database
🏥 Medical Devices Class I - Dangerous
DHEA-S causes falsely elevated progesterone results.
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
The See Clear Company
🏥 Medical Devices Class I - Dangerous
Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
🏥 Medical Devices Class I - Dangerous
The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Villa Sistemi Medicali S.P.A.
🏥 Medical Devices Class I - Dangerous
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
🏥 Medical Devices Class I - Dangerous
Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
🏥 Medical Devices Class I - Dangerous
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
MicroAire K-Wires
MicroAire Surgical Instruments
🏥 Medical Devices Class I - Dangerous
Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).
MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
🏥 Medical Devices Class I - Dangerous
Sterility compromised due to breach in sterile barrier
A-series lift - A625 Manual Part No. 324117. Prism Medical.
ErgoSafe Products, LLC (DBA) Prism Medical
🏥 Medical Devices Class I - Dangerous
During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.
🏥 Medical Devices Class I - Dangerous
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Merge PACS software. The firm name on the label is Merge Healthcare.
Merge Healthcare
🏥 Medical Devices Class I - Dangerous
Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
🏥 Medical Devices Class I - Dangerous
DHEA-S causes falsely elevated progesterone results.
🏥 Medical Devices Class I - Dangerous
DHEA-S causes falsely elevated progesterone results.
🏥 Medical Devices Class I - Dangerous
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.