FDAFDA · Food and drugs·Recall number Z-0001-2015
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Published October 8, 2014 · Recall initiated: September 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Invivo Corporation
- Distributor
- Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
- Lot
- Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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