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Recall Observatory FDA recall evidence

Device product

Philips Expression MR200 MRI Patient Monitoring System Model 866120

Z-0001-2015

September 08, 2014

Class II

Product summary

Firm
Invivo Corporation
Event
Event 69192
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-0001-2015

Official wording

Reason: During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.

Code information: Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013

Distribution pattern: Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.