GE Healthcare SIGNA Creator — Class II medical device recall Z-2731-2016
Terminated recall by GE Healthcare, LLC, reported 2016-09-14, distributed in AZ, CA, CT, FL, IL, MA, MO, MS…. GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREAT
| Recall number | Z-2731-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-08-31 |
| Classified | 2016-09-02 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2018-07-31 |
| Distributed | AZ, CA, CT, FL, IL, MA, MO, MS, NC, PR, TX, WI |
| Countries outside the US | AE, AU, BD, BE, BR, CA, CO, DE, DO, DZ, EG, ES, FR, GB, GH, GT, HK, HU, ID, IN, IR, IT, JM, JP, KR, KW, LB, LT, MA, MX, NL, NZ, OM, PH, PK, PL, PT, RO, SA, SE, SG, TH, TR, VN, ZA |
Product
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2731-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.