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-2398-2023
Product Description
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Reason for Recall
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
Details
- Recalling Firm
- Philips North America
- Units Affected
- 601 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: 601 Total.
Why was this product recalled? ▼
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 16, 2023. Severity: Moderate. Recall number: Z-2398-2023.
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