GE Healthcare — Class II medical device recall Z-1100-2013
Terminated recall by GE Healthcare, LLC, reported 2013-04-17, distributed nationwide. GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction
| Recall number | Z-1100-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-04-23 |
| Classified | 2013-04-11 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2014-03-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, ES, FR, GB, IN, JP, LB, NZ, SA, SE, SG |
| Quantity | 46 |
| Serial numbers | 00000000UA0010, 00000000UA0011A, 00000000UA0012, 00000000UA0013, 00000000UA0015, 00000000UA0016, 00000000UA0017, 00000000UA0018, 00000000UA0019, 00000000UA0020, 00000000UA0021, 00000000UA0022, 00000000UA0023, 00000000UA0024, 00000000UA0025, 00000000UA0027, 00000000UA0028, 00000000UA0029, 00000000UA0030, 00000000UA0031, 00000000UA0033, 00000000UA0034, 00000000UA0035, 00000000UA0036, 00000000UA0037 and 21 more |
| Model numbers | 5352293 |
Product
GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,blood vessels, and musculoskeletal regions of the body.
Reason for recall
GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.
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-1100-2013. 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.