FDA Device recall Z-1302-2018
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a de…
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a de… by Ge Healthcare, citing A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1302-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-23 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Reason
A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. 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 indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.
Identifiers
| code_info | Model Numbers: (a) 2052831-00X: Serial Numbers: 4285-1-Centricity PACS-IW-00558123 4479-1-Centricity PACS-IW-0055821…Model Numbers: (a) 2052831-00X: Serial Numbers: 4285-1-Centricity PACS-IW-00558123 4479-1-Centricity PACS-IW-00558214 4291-1-Centricity PACS-IW-00558194 4300-1-Centricity PACS-IW-00558207 100701-1-Centricity PACS-IW-00558322 100979-1-Centricity PACS-IW-00558142 4474-1-Centricity PACS-IW-00558169 1153-1-Centricity PACS-IW-00558162 100889-1-Centricity PACS-IW-00558190 100891-1-Centricity PACS-IW-00558184 100892-1-Centricity PACS-IW-00558192 100893-1-Centricity PACS-IW-00558171 100894-1-Centricity PACS-IW-00558200 10994-1-Centricity PACS-IW-00558177 100898-1-Centricity PACS-IW-00558176 100895-1-Centricity PACS-IW-00558195 100823-1-Centricity PACS-IW-00558175 100901-1-Centricity PACS-IW-00558151 100762-1-Centricity PACS-IW-01225872 100902-1-Centricity PACS-IW-00558180 100905-1-Centricity PACS-IW-00558181 100906-1-Centricity PACS-IW-00558165 100908-1-Centricity PACS-IW-00558158 100909-1-Centricity PACS-IW-00558198 100910-1-Centricity PACS-IW-00558178 100911-1-Cent |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1302-2018%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.