Recall Z-2266-2015— Philips Electronics North America Corporation

Name: FDA recall Z-2266-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-17

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-06-17, terminated 2019-10-02. It names one FDA 510(k) clearance: K124061. Product: Invivo Expression MRI Patient Monitoring System.. Reason: The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as Esophageal..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-06-17
Terminated: 2019-10-02
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K124061 — MRI PATIENT MONITORING SYSTEM (MODEL 865214)Invivo Corporation·cleared 2013-02-22

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

Invivo Expression MRI Patient Monitoring System.

Reason for recall

The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as Esophageal.

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