MR 7700 Magnetic Resonance — Class II medical device recall Z-2397-2023
Ongoing recall by Philips North America, reported 2023-08-16, distributed nationwide. The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detec
| Recall number | Z-2397-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-06-12 |
| Classified | 2023-08-10 |
| Reported by FDA | 2023-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 640 total |
| UPC / GTIN / UDI-DI | 00884838104112, 00884838104402 |
| Serial numbers | 45007, 45297, 45298, 45301, 45557, 65000, 65001, 65002, 65003, 65004, 65005, 65006, 65007, 65008, 65009, 65012, 65013, 65019, 65020, 65023, 65025, 65030, 65031, 65034, 65041 |
Product
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Reason for recall
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
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-2397-2023. 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.