FDA Device recall Z-2397-2023
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
- FDA Device
- Class II
- ongoing
- Published 2023-08-16
On 2023-08-16 the FDA classified a Class II recall of MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) by Philips North America, citing the system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2397-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-12 |
| Published | 2023-08-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Reason
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Identifiers
| code_info | Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 65008 6…Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 65008 65007 65006 65005 65004 65003 65002 65000 65020 65012 65034 65001; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 45301 45298 45007 45297 45557 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2397-2023%22
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