Z-0845-2014Class II

InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V)

Name: Z-0845-2014 InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V)
Creator: Philips Healthcare
Published: 2014-01-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-01-13 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare began a recall of InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended... on 2014-01-13. FDA classified it as Class II and gives the reason as "Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0845-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-13
Posted: 2014-01-27
Terminated: 2014-02-13
Recalling firm: Philips North America LLC
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
Product code: NCX System, Hypothermia, Intravenous, Cooling
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Healthcare Recall Notice for this proactive performance correction was provided verbally to hospital biomedical engineers. Philips product support engineering scheduled and conducted the update on customer devices to the most current MCB configuration.
Quantity in commerce: 50
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.
Product codes and lots: Model Numbers: 861470 (120V), 861472 (240V).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0845-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0845-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27

Product code NCX

K080908Class IIInnercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation / cleared 2008-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)