FDA Device recall Z-1214-2015
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare p…
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare p… by Ge Healthcare, citing using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &am….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1214-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-18 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.
Reason
Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp
Identifiers
| code_info | Catalog Number and Catalog Description: K2000YS , HCA 3.2 UPGRADE KIT (LX) ; K2000YT , HCA 3.2 UPGRADE KIT (S2L) ;…Catalog Number and Catalog Description: K2000YS , HCA 3.2 UPGRADE KIT (LX) ; K2000YT , HCA 3.2 UPGRADE KIT (S2L) ; K20241SG , C 3.2 TECH S/W CONCURRENT ; K20241SH , C 3.2 DIAG S/W CONCURRENT ; K20241SJ , C 3.2 CLIN S/W CONCURRENT ; K20241SK , C 3.2 TECH S/W SEAT ; K20241SL , C 3.2 DIAGNOSTIC S/W SEAT ; K20241SM , C 3.2 CLINICAL S/W SEAT ; K20241TS , CPACS SOL 2.1 TO LIN 4.0 ; K20241TT , CPACS SOL 3.X TO LIN 4.0 ; K20241TW , CPACS LIN 3.X TO LIN 4.0 ; K20241TY , CPACS LIN 2.X TO LIN 4.0 ; K2024SG , C 3.2 TECH S/W CONCURRENT ; K2024SH , C 3.2 DIAG S/W CONCURRENT ; K2024SJ , C 3.2 CLIN S/W CONCURRENT ; K2024SK , C 3.2 TECH S/W SEAT ; K2024SL , C 3.2 DIAGNOSTIC S/W SEAT ; K2024SM , C 3.2 CLINICAL S/W SEAT ; K2024TS , CPACS SOL 2.1 TO LIN 4.0 ; K2024TT , CPACS SOL 3.X TO LIN 4.0 ; K2024TW , CPACS LIN 3.X TO LIN 4.0 ; K2024TY , CPACS LIN 2.X TO LIN 4.0 ; K2024WH , CPACS S2.1 TO L4.0 SWOP ; K2024WJ , CPACS S3.X TO L4.0 SWOP ; K2024WK , CPACS L3.X TO L4.0 SWOP ; K202 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1214-2015%22
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