Recall Z-0958-2015— Invivo Corporation

Name: FDA recall Z-0958-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-22

Class II · Terminated

Class II FDA medical device recall by Invivo Corporation, initiated 2014-10-22, terminated 2017-01-09. It names one FDA 510(k) clearance: K131382. Product: Philips Expression MR200 MRI Patient Monitoring System.. Reason: The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock..

Recalling firm: Invivo Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-10-22
Terminated: 2017-01-09
Firm location: Orlando, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K131382 — EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTALInvivo Corporation·cleared 2013-07-15

K-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.

Reason for recall

The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.

Data sourced from openFDA. This site is unofficial and independent of the FDA.