FDA Device recall Z-0260-2016
GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron…
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron… 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-0260-2016 |
| 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 PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and isocentrically.
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 | 00000000UA0064 415723SHMRW 00000000UA0217 415CBMRP N/A 608262PETMR1 MAYOPETMR01 UABPETMR SI…00000000UA0064 415723SHMRW 00000000UA0217 415CBMRP N/A 608262PETMR1 MAYOPETMR01 UABPETMR SID TBD SID TBD 262574PETMR1 310974MR1 MRUA0459 309452MR1 082427HWBAY1 M40345211 N/A SID TBD SID TBD SID TBD 00001309FMM076 C001MR01 00000309668MR2 AC001MR02 00000307417MR6 120810MR03 |
|---|
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-0260-2016%22
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