FDA Device recall Z-2203-2012
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance…
- FDA Device
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance… by Ge Healthcare, citing GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2203-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-24 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2 Product Usage: Advantage Workstation version 4.2: The Advantage Workstation 4.2 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis. Advantage Workstation version 4.3/4.4 : The Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality DIACOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images of the AW monitor may be used as a basis for diagnosis, except in the case of mammography.
Reason
GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET serie
Identifiers
| code_info | FMI 25404 Additional Consignees Mfg Lot or Serial # System ID (As required) 00000020D6C6F IE1085AW02 00000029…FMI 25404 Additional Consignees Mfg Lot or Serial # System ID (As required) 00000020D6C6F IE1085AW02 00000029FDB24 A4194418 0000002A8C1D3 ws132201 0000002AB15AF PL1008AW03 00000L0201354A RJ0005 00000L02013776 HC9074AW01 00000L02013900 00137ADW03 00000L020140F4 10146ADW01 00000L02014128 PPR83607 00000L02014228 082421060040AW 00000L0201485E 813642AW42 00000L0201492C 864366AAW 00000L020149E4 083055065231713 00000L02014C1C 2526577 00000L0201521E 26329AW2 00000L02019460 617355AW3 00000L020194E0 919660AWMRI 00000L020195D0 352CDCAW43 00000L02019690 809780AW2 00000L02019696 510295ANAW 00000L020197FE 2535997AW42 00000L020198A8 WS98556 00000L02019944 706774AW2 00000L02019946 716887AW2 00000L0201994E 716887AW1 00000L02019A02 EG1277AW01 00000L02019ABA 617355AWPC1 00000L02019AE8 850475PAW 00000L0202AC34 082416310006AW 00000L0202AEB4 600160AW01 00000L0202AECA 083055822100526 00000L0202B4AA CC4400AW03 00000L0202B4B8 083049062634502 00000L0202B4BF 083049802101 |
|---|
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-2203-2012%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.