GE Discovery MR950 MRI system — Class II medical device recall Z-1395-2015
Terminated recall by GE Healthcare, reported 2015-05-13, distributed in CA. The alignment lasers are missing the labels required by radiation safety regulations.
| Recall number | Z-1395-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2014-10-24 |
| Classified | 2015-05-01 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-05-06 |
| Distributed | CA |
| Countries outside the US | IT, JP |
| Quantity | 5 units |
| Reason classes | labeling |
Product
GE Discovery MR950 MRI system
Reason for recall
The alignment lasers are missing the labels required by radiation safety regulations.
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-1395-2015. 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.