PlainRecalls
FDA Devices Moderate Class II Ongoing

MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

Reported: August 16, 2023 Initiated: June 12, 2023 #Z-2397-2023

Product Description

MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

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?
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700). 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-2397-2023.