FDA-Device2014-10-08Class II
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Invivo Corporation
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.
Sold states
Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
Affected count
10 units
Manufactured in
12151 Research Pkwy, Suite 200, Orlando, FL, United States
Products
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2015Don't want to check this manually?
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