|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to ass...
|
2
|
09/29/2021
|
Shanghai United Imaging Healthcare Co., Ltd.
|
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by ...
|
2
|
08/13/2020
|
Shanghai United Imaging Healthcare Co., Ltd.
|
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the dista...
|
2
|
08/20/2015
|
Stryker Howmedica Osteonics Corp.
|
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professiona...
|
2
|
09/29/2021
|
Shanghai United Imaging Healthcare Co., Ltd.
|
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated b...
|
2
|
08/13/2020
|
Shanghai United Imaging Healthcare Co., Ltd.
|
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trai...
|
2
|
07/08/2020
|
Shanghai United Imaging Healthcare Co., Ltd.
|
uCT 530 Computed Tomography X-Ray System
|
2
|
06/30/2020
|
Shanghai United Imaging Healthcare Co., Ltd.
|
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc.
thermage RF GENERATOR REF TG-2B ***...
|
2
|
04/07/2023
|
Solta Medical Inc
|
therascreen ®KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument...
|
2
|
09/29/2023
|
Qiagen GmbH
|
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer pati...
|
2
|
01/29/2021
|
Qiagen Sciences LLC
|