Recall Z-0845-2014— Philips Healthcare

Name: FDA recall Z-0845-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-13

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare, initiated 2014-01-13, terminated 2014-02-13. It names one FDA 510(k) clearance: K080908. Product: InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908. Reason: Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm..

Recalling firm: Philips Healthcare
Classification: Class II
Status: Terminated
Initiated: 2014-01-13
Terminated: 2014-02-13
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K080908 — INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEMInnercool Therapies, Inc.- A Delaware Corporation·cleared 2008-10-17

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

InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

Reason for recall

Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.

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