FDA Device recall Z-0693-2019
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
- FDA Device
- Class II
- terminated
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use by Ge Healthcare, citing possible incorrect software version loaded.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0693-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-15 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
Reason
Possible incorrect software version loaded.
Identifiers
| code_info | Product Name Sold Under System ID Model # *WH*MR SIGNA 1.0T HORIZON 5.X HISPE GPX23300 2108050 0.2T SIGNA PROFILE 276…Product Name Sold Under System ID Model # *WH*MR SIGNA 1.0T HORIZON 5.X HISPE GPX23300 2108050 0.2T SIGNA PROFILE 2761614-1 5179427 0.7T OPENSPEED EXITE PC7479MR06 2377062-5 0.7T OPENSPEED EXITE PC3802MR02 2377062-5 1,5T HD ES/HS 10079MRM74 5107849 1.0T SIGNA LX PH0095MR01 2214149 1.0T SIGNA LX PC0125MR02 2189500-3 1.5 ECHOSPEED HD 16-CH 0850270514 2226300 1.5 ECHOSPEED HD 4-CH 200-AP 409838HDCMR1 46-294231G1 1.5 ECHOSPEED HD 4-CH 200-AP 940220MR1 2214149-2 1.5 ECHOSPEED HD 8-CH 400-A 1344119 2226300 1.5 ECHOSPEED HD 8-CH 400-A 2624537EXCITE 5107849-2 1.5 ECHOSPEED HD 8-CH 400-AP 760323MR 2214149-2 1.5 ECHOSPEED HD 8-CH 400-AP 60001MRS01 5323286-101 1.5 HDE 8CH 3882691524MRCTR 5139394-2 1.5 HISPEED 3882635801MRSOR 2226300 1.5 HISPEED 4C 412099MR1 2226300 1.5 HISPEED HD 8-CH 400-AP 317338MR4 2214149-2 1.5 HISPEED HD 8-CH 400-AP 803936MRI 2214149-2 1.5 LX TO HDX 16C FORKLIFT UPG 614293MR7 2214149-2 1.5 SIGNA EXPLORER DZ1947MR01 5323286-101 1.5 SIGNA EXPLORER DZ1149M |
|---|
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-0693-2019%22
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