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Invivo Corporation recalls Philips Expression MR200 MRI Patient Monitoring System Model 866120
Recalled October 8, 2014 · FDA recall Z-0001-2015 · Invivo
Hazard
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. · FDA Class II
Units
10 units
Sold at
Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
Description
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.
Product
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Manufacturer(s)
Invivo Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →