FDA Device recall Z-1533-2014
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery…
- FDA Device
- Class II
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class II recall of GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery… by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release ha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1533-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-23 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | DC, ND, PR, RI, WY |
Product
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.
Reason
GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.
Identifiers
| code_info | Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 746…Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR 00000295024MR4 207945MR750 00001250FMM033 207OA450WMR 00000305461MR6 208882MR450W 00000299644MR5 209225VC450 00001026XF5173 209225VC750 00001105XF502C 209SJMR 00000000UA0143 210617HUBMR 00000300706MR9 210MSMTMR 00000000UA0052 21277MR1 00000301045MR1 212989MR1 00000305990MR4 212GE450W 00000301820MR7 214266PCBCMR1 00000302494MR0 214302PDWMR1 00000300930MR5 214590MWMRE3 00001250FMM02W 214645UT3TMR1 00000030251MR2 215ARIA450W 00000304079MR7 217223BHMR |
|---|
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-1533-2014%22
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