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Invivo Corporation recalls Philips Expression MR200 MRI Patient Monitoring System.
Recalled January 21, 2015 · FDA recall Z-0958-2015 · Invivo
Hazard
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. · FDA Class II
Units
20
Sold at
CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.
Description
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.
Product
Philips Expression MR200 MRI Patient Monitoring System.
Manufacturer(s)
Invivo Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →