Recall Z-2867-2016— Invivo Corporation
Class II · Terminated
Class II FDA medical device recall by Invivo Corporation, initiated 2014-09-14, terminated 2016-12-14. It names one FDA 510(k) clearance: K121424. Product: Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.. Reason: Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014..
- Recalling firm
- Invivo Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-14
- Terminated
- 2016-12-14
- 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 Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
Reason for recall
Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.
Data sourced from openFDA. This site is unofficial and independent of the FDA.