FDA Device recall Z-0254-2016
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima M…
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima M… by Ge Healthcare, citing when performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value fr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0254-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-31 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
Reason
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Identifiers
| code_info | 00000302690MR3 HCIMR1805 00000290502MR4 MR129030 00000291489MR3 415723SHMR10 00000294472MR6 650723SSMR1 00000290704…00000302690MR3 HCIMR1805 00000290502MR4 MR129030 00000291489MR3 415723SHMR10 00000294472MR6 650723SSMR1 00000290704MR6 650723SSMR2 00000289310MR5 HSSMR750 00000289961MR5 SINAI750MR 00000290457MR1 608263MR6 00000290050MR4 281276MR750 00000290659MR2 610740MR3 00000290202MR1 415723CHMR2 290957MR0 608HERIMR 00000290636MR0 MR129034 00000290137MR9 650723NCMR1 00000289309MR7 650723NCMR2 00000291397MR8 517353DVMR 00000291363MR0 616391DVMR 00000291980MR1 704384DVMR 00000292367MR0 INSIGHTMR3228 00000292471MR0 804675VA3T 00000288408MR8 608WAISMR 00000292634MR3 2486613TMR 00000288907MR9 MR129035 00000292431MR4 541CMRIMR 00000290773MR1 415L3TMR2 00000291877MR9 415L3TMR1 00000291185MR7 MSK65MR1 00000292528MR7 608WIMRMR2 00000291244MR2 MSK65MR2 00000293338MR0 206CH750MR 00000291464MR6 217528MR1 00000292843MR0 217788MR3 00000294556MR6 540665MR3T 00000293261MR4 415OI3TMR 00000293015MR4 910907WAMR1 00000292678MR0 919684MR5 00000293561MR7 405752I3T 00000293874MR4 HSSG |
|---|
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-0254-2016%22
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