Azure S DR MRI SureScan — Class II medical device recall Z-1924-2025
Ongoing recall by Medtronic, Inc., reported 2025-06-18. Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, an
| Recall number | Z-1924-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, Inc., Mounds View, MN, United States |
| Recall initiated | 2025-04-29 |
| Classified | 2025-06-06 |
| Reported by FDA | 2025-06-18 |
| Countries outside the US | GB |
| Quantity | 6 |
| UPC / GTIN / UDI-DI | 00763000956004 |
| Serial numbers | RNJ108800G, RNJ108803G, RNJ108804G, RNJ108808G, RNJ108810G, RNJ108820G |
Product
Azure S DR MRI SureScan, Product number W3DR01
Reason for recall
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
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-1924-2025. 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.