GE Healthcare — Class II medical device recall Z-1209-2013
Terminated recall by GE Healthcare, LLC, reported 2013-05-08, distributed nationwide. GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axi
| Recall number | Z-1209-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-06-08 |
| Classified | 2013-05-01 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2014-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KR, KW, LB, LT, LU, LV, MA, MX, MY, NG, NL, NO, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UY, VE, VN, ZA |
| Serial numbers | 160222HM6, 162548HM2, 163410HM4, 165274HM2, 165275HM9, 165776HM6, 166009HM1, 166315HM2, 167093HM4, 167486HM0, 168057HM8, 168297HM0, 168298HM8, 168747HM4, 168931HM4, 169411HM6, 169412HM4, 170080HM6, 170081HM4, 170572HM2, 170573HM0, 170636HM5, 170946HM8, 170947HM6, 171317HM1 and 475 more |
Product
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.
Reason for recall
GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers
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-1209-2013. 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.