Philips MR 7700 Magnetic Resonance System Smoke Detector Interlock Bypass
Philips MR 7700 MRI systems can have their smoke detector interlock safety mechanism bypassed when power cycled after smoke detection, allowing continued operation despite potential fire hazards.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a compromised safety interlock that can be bypassed. No reported illnesses or injuries, but the defect presents a risk-of-harm to patients and staff by allowing continued MRI operation during fire hazards.
Plain-English summary
Philips North America is recalling the MR 7700 Magnetic Resonance (MR) system, a medical imaging device used in clinical facilities. The recalled units include Product Numbers 782120 and 782130, with a total of 640 units distributed nationwide and globally.
The recalled systems contain a defect in the SmokeDetector Interlock system. Operators can bypass this safety interlock mechanism by power cycling the device immediately after smoke detection, allowing the system to resume operation without the smoke detection safety feature being fully active.
The SmokeDetector Interlock is designed to prevent MR system operation when smoke is detected, protecting against fire hazards. When this safety mechanism can be bypassed, the MRI system may continue operating under conditions where a fire hazard exists, putting patients and staff at risk.
Healthcare facilities with affected MR 7700 systems should contact Philips North America for service instructions. Do not power cycle the system after smoke detection to resume operations, and ensure the SmokeDetector Interlock functions properly before each clinical use.
The recalled product
- Product
- MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
- Manufacturer
- Philips North America
- Hazard
- safety-interlock-bypass
- fire-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Number: 782120: UDI-DI: 00884838104112
- Product Number 782130: UDI-DI: 00884838104402
- Serial Numbers: 45301 45298 45007 45297 45557
Distribution
Distributed nationwide across the United States.
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