GE Healthcare — Class II medical device recall Z-0260-2016
Terminated recall by GE Healthcare, reported 2015-11-18, distributed nationwide. When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in t
| Recall number | Z-0260-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-08-31 |
| Classified | 2015-11-09 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2018-09-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BM, BR, CA, CH, CN, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JM, JP, KR, KW, LB, LU, MX, MY, NL, NO, NZ, PE, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, TH, TR, TW, UY, VE, ZA |
| Quantity | 17 |
Product
GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and isocentrically.
Reason for recall
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.
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-0260-2016. 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.