FDA Device recall Z-1781-2019
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228…
- FDA Device
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228… by Ge Healthcare, citing there is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1781-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-22 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
Reason
There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
Identifiers
| code_info | a) 2052831-00x, Lot or Serial Numbers: 100839-1-Centricity PACS-IW-00558122 100893-1-Centricity PACS-IW-00558171 432…a) 2052831-00x, Lot or Serial Numbers: 100839-1-Centricity PACS-IW-00558122 100893-1-Centricity PACS-IW-00558171 4320-1-Centricity PACS-IW-00558202 4474-1-Centricity PACS-IW-00558169 2455-1-Centricity PACS-IW-00558139 100863-1-Centricity PACS-IW-00558143 100794-1-Centricity PACS-IW-00558193 4346-1-Centricity PACS-IW-00558136 100909-1-Centricity PACS-IW-00558198 4355-1-Centricity PACS-IW-00558204 100809-1-Centricity PACS-IW-00558124 4300-1-Centricity PACS-IW-00558207 4484-1-Centricity PACS-IW-00558213 4479-1-Centricity PACS-IW-00558214 13240-2-Centricity PACS-IW-01225875 4270-1-Centricity PACS-IW-00558129 11059-2-Centricity PACS-IW-00558101 101598-1-Centricity PACS-IW-00667133 4273-1-Centricity PACS-IW-01225873 4357-1-Centricity PACS-IW-00558444 4293-1-Centricity PACS-IW-00558131 100835-1-Centricity PACS-IW-00558568 100900-1-Centricity PACS-IW-00558170 4344-1-Centricity PACS-IW-00558196 3836-1-Centricity PACS-IW-00558179 4428-1-Centricity PACS-IW-00558205 1006 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1781-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.