Recall Z-0069-2015— Invivo Corporation

Name: FDA recall Z-0069-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-05

Class II · Terminated

Class II FDA medical device recall by Invivo Corporation, initiated 2014-09-05, terminated 2017-10-12. It names one FDA 510(k) clearance: K131382. Product: Philips Expression MR200 MRI Patient Monitoring System. Reason: Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement..

Recalling firm: Invivo Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-09-05
Terminated: 2017-10-12
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

Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.

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