Recall Z-0012-2022— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-08-12, terminated 2024-08-22. It names one FDA 510(k) clearance: K182419. Product: Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system. Reason: 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)..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-12
- Terminated
- 2024-08-22
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.