InnerCool RTx Endovascular System recall
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system…
Why was InnerCool RTx Endovascular System recalled?
Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Numbers: 861470 (120V), 861472 (240V).
- Product
- InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system…
- Recalling firm
- Philips Healthcare
- Quantity
- 50
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.
- Recall date
- February 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)