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Recall Observatory FDA recall evidence

Device product

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

Z-2400-2023

June 12, 2023

Class II

Product summary

Firm
Philips North America
Event
Event 92727
Status
Ongoing
Classification
Class II
Quantity
601 total
Official record key
device-enforcement:Z-2400-2023

Official wording

Reason: 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.

Code information: Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 6500865007 65006 65005 65004 65003 65002 65000 65020; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 4530145298 45007 45297

Distribution pattern: US Nationwide. Global Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.