ProxiDiagnost N90
Philips North America
🏥 Medical Devices Class I - Dangerous
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
🏥 Medical Devices Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
🏥 Medical Devices Class I - Dangerous
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
🏥 Medical Devices Class I - Dangerous
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
🏥 Medical Devices Class I - Dangerous
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
🏥 Medical Devices Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
🏥 Medical Devices Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
🏥 Medical Devices Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
🏥 Medical Devices Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
🏥 Medical Devices Class I - Dangerous
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
🏥 Medical Devices Class I - Dangerous
FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
Ameditech
🏥 Medical Devices Class I - Dangerous
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
🏥 Medical Devices Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
🏥 Medical Devices Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
🏥 Medical Devices Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.