Z-0001-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2014
- Initiation Date
- September 8, 2014
- Termination Date
- January 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
Code Information
Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013