FDA Device recall Z-2339-2015
GE Healthcare, Signa Infinity MR System
- FDA Device
- Class II
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of GE Healthcare, Signa Infinity MR System by Ge Healthcare, citing A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2339-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-10 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi. Whole body magnetic resonance diagnostic imaging scanners.
Reason
A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000153282MR9 501362MR1 00000165901MR0 ZA2101MR02 00000213818MR8 37190MRI 0000021334…Mfg Lot or Serial # System ID 00000153282MR9 501362MR1 00000165901MR0 ZA2101MR02 00000213818MR8 37190MRI 00000213341MR1 M27590 00000247386MR6 707459MR2 00000231538MR0 706583MR 00000236418MR0 850862FTS1CH1 00000242668MR2 502868MR 00000267704MR5 314525SAMR2 00000227724MR2 ALLIANCESIG262 00000214667MR8 853270051 00000242173MR3 ALLIANCESIG287 00000241518MR0 502633MR1 00000231910MR1 212956MR2 00000237000MR5 0910272037 00000241867MR1 HU1008MR01 00000243769MR7 920279006 00000047514WH5 YM0774 00000285490MR9 954916MR1 00000284687MR1 309655MRI1A 00000280860MR8 1202470 00000282692MR3 902496MRI3 00000282813MR5 0835270010 00000278669MR7 508755MR1 00000267211MR1 0850270458 000000HDMR3141 SHIMR598 000000HDMR5777 919470MR2 000000HDMR3905 709737MRI 000000HDMR2541 M4018076 000000HDMR5379 M4135138 00000HDMR10710 10543MRM01 00000301019MR6 SMSDML2 00000292334MR0 INSIGHTMR1915 00000290735MR0 704323MR1 00000300812MR5 MR14604YR3 00000297420MR2 082427080028 00000239401MR3 4 |
|---|
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-2339-2015%22
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