Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammogra
FDA device recall Z-2503-2021 · posted 2021-09-22 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
- Action taken
- This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 06, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 462 (279 US; 183 OUS)
- Distribution
- AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV and WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Irela
- Date initiated
- 2021-08-06
- Date posted
- 2021-09-22
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Centricity Universal Viewer (K150420) | GE Healthcare | 2015-05-26 |