Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Reported: August 16, 2023 Initiated: June 12, 2023 #Z-2395-2023
Product Description
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
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.
Details
- Recalling Firm
- Philips North America
- Units Affected
- 640 total
- Distribution
- US Nationwide. Global Distribution.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X). Recalled by Philips North America. Units affected: 640 total.
Why was this product recalled? ▼
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 16, 2023. Severity: Moderate. Recall number: Z-2395-2023.
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