GE Healthcare — Class II medical device recall Z-0553-2016
Terminated recall by GE Medical Systems, LLC, reported 2018-10-31, distributed in AZ, CA, CO, DC, DE, FL, IL, IN…. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient therm
| Recall number | Z-0553-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2015-12-07 |
| Classified | 2018-10-22 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2018-11-08 |
| Distributed | AZ, CA, CO, DC, DE, FL, IL, IN, MD, ME, MI, MN, MO, NC, NH, NY, OH, OK, OR, PA, PR, SD, TN, TX, VA, WI |
| Countries outside the US | AU, BR, CA, CH, CN, CZ, DE, EE, EG, ES, FR, GB, ID, IT, JP, KR, KW, MX, NL, NZ, PL, PT, RO, RU, SA, SE, TR, TW, ZA |
| Reason classes | device malfunction |
Product
GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
Reason for recall
Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been 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-0553-2016. 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.