Philips Expression MR200 MRI Patient Monitoring System recall
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Why was Philips Expression MR200 MRI Patient Monitoring System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
- Product
- Philips Expression MR200 MRI Patient Monitoring System Model 866120
- Recalling firm
- Invivo Corporation
- Quantity
- 10 units
- Distribution
- Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
- Recall date
- October 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)