Device recall: InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx…
Class II FDA enforcement event 67319. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Philips Healthcare started this device recall on 13 Jan 2014. The firm address in the FDA record is in San Diego, CA. FDA put the recall in Class II. FDA event 67319 has 1 product record. The first FDA enforcement report date is 5 Feb 2014. The record gives the status Terminated, with the termination date 13 Feb 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.
Recalling firm
Philips Healthcare, San Diego, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0845-2014 | 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 | 50 | Class II | Terminated | 5 Feb 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 10
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Aug 2023 | Incisive CT, software version 5.0 | Device | Class II | 1 |
| 2 Feb 2022 | Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x | Device | Class II | 1 |
| 24 Sep 2021 | Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) | Device | Class II | 1 |
| 22 Sep 2021 | DigitalDiagnost C90 | Device | Class II | 3 |
| 26 May 2021 | Azurion systems with software release R2.0.x | Device | Class II | 1 |
| 21 Dec 2018 | DigitalDiagnost C50, Stationary X-ray System | Device | Class II | 1 |
| 11 Jun 2018 | Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interven | Device | Class II | 3 |
| 10 Nov 2015 | Philips Healthcare DigitalDiagnost stationary X-ray system | Device | Class II | 2 |
| 6 Sep 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-Ray System | Device | Class II | 7 |
Official channels
- FDA enforcement report Z-0845-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 67319. https://recallregister.com/fda/ii/67319/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.
- What quantity of product is in FDA event 67319?
- The FDA record gives this quantity:
50
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.