Class II — GE Healthcare
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series. |
| Product | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a) 2089507-120; b) 2089507-129; c) 2089507-131; d) 2089507-135; e) 2089507-136; f) 2089507-140; g) 2089507-144; h) 2089507-145; i) 2089507-149; j) 2089507-153; k) 2089507-154; l) 2089507-155; m) 2089507-156; n) 2089507-157; o) K2037DAED; p) K2037DBED; q) K2037DED; r) K2037DJED; s) K2037DNED; t) K2042TTED; u) K2049DC; v) K2049DD; w) K2049DF; x) P… |
| Quantity | 1500 units |
| Distribution | Worldwide distribution. |
| Initiated | 2024-08-29 |
| Classified | 2024-10-09 |
| Recall number | Z-0039-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare (Z-0039-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95307/
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