FDA Device recall Z-0258-2016
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic…
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic… 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-0258-2016 |
| 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 HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
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 | 002003-0922-04 713441MR5 1583678 732632MR3 002003-1015-09 713441MR7 00001009BD6576 713792AMR12 000000HDMR5656 41726…002003-0922-04 713441MR5 1583678 732632MR3 002003-1015-09 713441MR7 00001009BD6576 713792AMR12 000000HDMR5656 417269MRS1 00000HDMR10766 623433MR1 00000265552MR0 9525413TMR 00000026005MR8 503215MR1 002004-1102-17 7705353TMR 00000265805MR2 ACB41121MR HDMR5274 CBICMR1 0002005-0606-3 615284MR3T 000000HDMR5581 503216MR3 000000HDMR2301 269342MR3T 000000HDMR3234 303340MR 00000273869MR8 214345SWD3TMR1 000000HDMR2559 805GI3T HDMR2980 732223MR 00000275049MR5 706UGA3T 00000275649MR2 719595MR 00000275647MR6 3173383T1 #N/A 919684MR3 00000276435MR5 901226MR1 1002BD63EF 719542MR 00000275050MR3 631427MR3T 00000276722MR6 5857853T #N/A 5857853TTIP 00000273253MR5 717975MR3 00000007498YR9 212288GE3T 00000275967MR8 850916A3T 00000275648MR4 908725MR 00000278851MR1 425297RMR 00000006726YR4 COR373216 HM3652 715839MR3T 00000007556YR4 210617TCAMR2 00000HDMR10718 773665MR3T 00000278679MR6 708383WS3T 00000279918MR7 515643MR3T 00000279614MR2 904996MR3T 00000271119MR0 513556MR |
|---|
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-0258-2016%22
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