Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
FDA device recall Z-0012-2022 · posted 2021-10-02 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
- Action taken
- This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 13, 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
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 49
- Distribution
- AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom
- Date initiated
- 2021-08-12
- Date posted
- 2021-10-02
- Date terminated
- 2024-08-22
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Centricity Universal Viewer (K182419) | GE Healthcare | 2018-12-14 |