Reported Oct 8, 2014 · Terminated
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Invivo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Invivo Corporation · 12151 Research Pkwy · Orlando, FL · 32826-3222
Is this the product you have?
- Philips Expression MR200 MRI Patient Monitoring System Model 866120
- Lot codes and dates
- Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
- Amount recalled
- 10 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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