Ingenia Elition S MR System smoke detection interlock vulnerable to operator bypass
Philips Ingenia Elition S MR systems can be circumvented by power cycling to bypass the smoke detection safety interlock that locks after smoke is detected. This could allow continued operation despite 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: This is a Class II recall with no reported injuries or illnesses. However, it involves a risk-of-harm scenario where a critical safety mechanism (smoke detection interlock) can be circumvented on medical imaging equipment, matching the rubric criterion for High severity.
Plain-English summary
Philips is recalling certain Ingenia Elition S Magnetic Resonance (MR) systems (Product Numbers 781357 and 782106) due to a safety mechanism vulnerability.
The SmokeDetector Interlock is designed to lock the system when smoke is detected. However, operators can bypass this interlock by power cycling the system, potentially allowing the equipment to restart despite the presence of smoke.
Approximately 640 units have been distributed nationwide and globally. Operators and facility managers should verify their equipment's serial number against the recall notice and consult with Philips regarding this safety issue.
The recalled product
- Product
- Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
- Manufacturer
- Philips North America
- Affected units
- 640
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 (1)
- Product Number: 782150: UDI-DI: N/A Serial Numbers: 26003 26010 26006 26001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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