FDA Device recall Z-0257-2016
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imag…
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imag… 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-0257-2016 |
| 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, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles.
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 | 002005-1018-15 352333MR3T 000006-0523-13 716859MR3T 00001003BD6425 352376MR3T2 00000280001MR9 MR129031 00000285499M…002005-1018-15 352333MR3T 000006-0523-13 716859MR3T 00001003BD6425 352376MR3T2 00000280001MR9 MR129031 00000285499MR0 2154563TMR 000000HDMR3702 RADNETMR554 00000274930MR7 805CHLIMR1 00000280057MR1 513558MR3T 00000274998MR4 213977MR2 002004-0713-06 ACB41109MR 002004-0406-08 323442MR2 002004-0406-15 323442MR1 00000273396MR2 7326133T 002004-1115-19 865373MR1 002005-0316-05 7576713T 0002005-0606-4 205750MR2 00000274839MR0 9287573TMR 002006-0119-15 559325CIIMR1 0002005-1201-3 256734MR3T 002005-1003-15 201487MR 000000HDMR2996 6053223TMR 000000HDMR3245 775RDC3T 002005-0620-16 405634S3T 00000269460MR2 602406IMR 00000275670MR8 813972VAMR 0002005-1121-7 480614MR1 00000273230MR3 602689MR1 002005-1201-20 601288MR3T 00000275936MR3 ALLIANCESIG463 00000275086MR7 650306SMR3T 00000275162MR6 772VRAMR3T 00000273459MR8 360397MR2 0002005-0104-5 662841MR4 000006-0511-20 336852SEMR 00000278626MR7 228KAFBMR3T 00000278619MR2 806212MR3T 00000278722MR4 337261MR1 00000281703MR |
|---|
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-0257-2016%22
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