FDA Device recall Z-2731-2016
GE Healthcare SIGNA Creator, SIGNA Explorer
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of GE Healthcare SIGNA Creator, SIGNA Explorer by Ge Healthcare, citing GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected ther….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2731-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-31 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | AZ, CA, CT, FL, IL, MA, MO, MS, NC, PR, TX, WI |
Product
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Reason
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
Identifiers
| code_info | Mfg Lot or Serial # System ID MNEXP1600002MR 480425MR7 001709TA5 520ASRMR 003175TA7…Mfg Lot or Serial # System ID MNEXP1600002MR 480425MR7 001709TA5 520ASRMR 003175TA7 916RAFMR 002448TA9 559449SPMR 002674TA0 559449SPMR 002027TA1 203337MREXP 003012TA2 GON: 4371049 002974TA4 239458MR1 003399TA3 239292MR1 002380TA4 305983MR3 002753TA2 727869MR 003356TA3 954473MR1 003176TA5 773843SCMR 000753TA4 574206MR 003013TA0 508746JMR2 003019TA7 417269MRS2 003371TA2 601853MR1 001027TA2 704384MINT 001059TA5 7 04384MINT 002453TA9 513569MR1 002741TA7 513584MR 001063TA7 254965CTOMR1 002879TA5 920560EXP 002831TA6 GON: 1532602 002023TA0 DZ1035MR03 002081TA8 DZ1863MR01 003302TA7 GON: 4399202 002742TA5 GON: |
|---|
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-2731-2016%22
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