FDA Device recall Z-2131-2016
GE Healthcare, Discovery MR750w
- FDA Device
- Class II
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class II recall of GE Healthcare, Discovery MR750w by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally acce….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2131-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-08 |
| Published | 2016-07-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | AK, AZ, CA, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY |
Product
GE Healthcare, Discovery MR750w
Reason
GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00001250FMM03D 9075653T 00001308FMM00B 602863MR Missing_SN_GON4205067 480342MR3 00001…Mfg Lot or Serial # System ID 00001250FMM03D 9075653T 00001308FMM00B 602863MR Missing_SN_GON4205067 480342MR3 00001134FMM10E 928348MR 00001140FMM0FX RADNETMR597 N/A 530CHI750W N/A 858824MR1 00000000UA0083 408356MR1 00001204FMM058 RADNETMR599 00000000UA0262 949760MR3 00000308185MR8 510449MR750W 00000000UA0075 619543HDMR4 00000000UA0118 858622HDMR1 00001204FMM052 415CB3TW 00001309FMM08B RADNETMR613 00001307FMM09Y 415UCBHMR3 1-4G33-86 805739MR3 310871MR9 310264MR2 309905MR8 RADNETMR621 00001204FMM04G 559734VIMR1 000005373011-3 RADNETMR598 N/A 720848MR4 N/A 720848MR3 311108MR5 303492MR 00001118FMM0WE 303604MR2 00001309FMM09E 720854MR 00000000UA0472 719365MR Missing_SN_GON4077136 303837MR2 309815MR9 970624MR1 310950MR1 860446MR750W 00001251FMM00R 202966MR3TW Missing_SN_GON4231312 561955MR1 00001309FMM097 386FNSBMR3T 00001308FMM042 954355MR750W 1309FMM09F 904483MR3T 00000000UA0465 305665MR750W 00001204FMM057 305461MR1 00001140FMM0FG 407SMSLMR1 00001147F |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2131-2016%22
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