FDA Device recall Z-1305-2015
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T,…
- FDA Device
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II recall of GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T,… by Ge Healthcare, citing GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1305-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-09 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems
Reason
GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000301098MR0 AL4023MR01 AL4004MR01 AL400…Mfg Lot or Serial # System ID 00000301098MR0 AL4023MR01 AL4004MR01 AL4009MR01 00000346726YM3 DZ1004MR01 000000HDMR5247 DZ1009MR02 00000267807MR6 DZ1057MR01 00001251FMM01J DZ1006MR01 00000305201MR6 DZ1101MR01 000000HDMR6342 DZ1250MR01 00000002790M24 DZ1396MR01 00000000175M20 DZ1102MR01 00000311125HM9 DZ1072MR01 00000004368M27 DZ1547MR01 00000003534M25 DZ1339MR02 00000005640M28 DZ1339MR01 00001010BD6611 DZ1090MR01 00000015868GQ3 DZ1259MR01 00001011BD667C DZ1005MR01 00000272532MR3 DZ1193MR01 00000005809M29 DZ1598MR01 00000311119HM2 DZ1061MR01 000000HDMR5358 DZ1260MR01 00000290691MR5 DZ1261MR01 00000172500MR1 DZ1033MR02 00000004987M24 DZ1064MR02 00000005787M27 DZ1204MR01 00000009356GQ7 DZ1128MR01 00000306373MR2 DZ1525MR01 00000005637M24 DZ1605MR01 00000099206HM5 DZ1149MR01 00000180852MR6 4406SIGNAMRI 00000002740M29 MRR8513 00000291189YM9 34874SIGNA 00000005153M22 MRR9924 00000147993MR0 132HORIZON 00000305908MR6 |
|---|
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-1305-2015%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.