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Recall Observatory FDA recall evidence

Device product

Philips Expression MR200 MRI Patient Monitoring System.

Z-0958-2015

October 22, 2014

Class II

Product summary

Firm
Invivo Corporation
Event
Event 69587
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-0958-2015

Official wording

Reason: The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.

Code information: Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.

Distribution pattern: CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.