Recall Z-0001-2015— Invivo Corporation
Class II · Terminated
Class II FDA medical device recall by Invivo Corporation, initiated 2014-09-08, terminated 2017-01-09. It names one FDA 510(k) clearance: K131382. Product: Philips Expression MR200 MRI Patient Monitoring System Model 866120. Reason: 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..
- Recalling firm
- Invivo Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-08
- Terminated
- 2017-01-09
- Firm location
- Orlando, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.