FDA Device recall Z-0259-2016
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scan…
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scan… 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-0259-2016 |
| 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 HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are 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 | 00000275183MR1 609652MR3T 00000848BD5339 2145903TXMRE5 000000HDMR3480 MR98508 000000HDMR5861 865545MR3T 002004-0513…00000275183MR1 609652MR3T 00000848BD5339 2145903TXMRE5 000000HDMR3480 MR98508 000000HDMR5861 865545MR3T 002004-0513-07 617754MR4 002004-0701-18 3137453TMR 000000HDMR2370 NYP347652 002004-0701-15 713704HMR4 000000HDMR3070 517353VH3 00000HDMR20151 313294MR 002004-0917-18 617754MR5 002004-0930-12 615TANMR 002005-0114-20 614722MR3 002005-0127-08 513451MR2 000000000R4044 661CBCCMR 000000HDMR4161 203863MR3T 000000HDMR3916 313593MR3T 002005-0328-17 2709263HD 00000HDMR20114 419383MR3T 000000HDMR2328 7067213TMR 00000930BD5D54 801588MR2 002004-0520-04 615777MR3T 000000HDMR1169 LONGWOOD30MR2 000000HDMR3396 3096653TMR 000000HDMR2818 402552NMC2 000000HDMR2952 415600D3T 00000266754MR1 423844MR2 000000HDMR2721 212305MR83T 000000HDMR3624 RADNETMR1521 00000011015YR5 928317MR1 000000HDMR2854 619543MR2 000000HDMR2481 703478MR5 0948BD61FA 509758TMR 00000275288MR9 831423MR 000000HDMR5864 480425MR5 00000274078MR5 510MIA3T 0000006-0425-3 610433MR 002005-1212-15 602406MR6 |
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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-0259-2016%22
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