FDA Device recall Z-1232-2022
Centricity Cardiology CA1000
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Centricity Cardiology CA1000 by Ge Healthcare, citing potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1232-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-28 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Centricity Cardiology CA1000
Reason
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Identifiers
| code_info | a. Software Version 1.0 through 1.0 SP, No GTIN/DI (Code: 2022296-0XX); b. Software Version 2.0 through 2.0 SP14H, GTI…a. Software Version 1.0 through 1.0 SP, No GTIN/DI (Code: 2022296-0XX); b. Software Version 2.0 through 2.0 SP14H, GTIN/DI: 00840682125260 (Codes: 2038437-0XX, 2097190-0XX) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-23 · Ge Healthcare - Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1232-2022%22
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