Philips Healthcare Recalls InnerCool RTx Endovascular Systems Due to Temperature Reading Errors
Philips Healthcare is recalling 50 InnerCool RTx Endovascular Systems because the main control board may display inaccurate low patient temperature readings and trigger false alarms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could lead to inaccurate patient monitoring, representing a risk-of-harm product where specific injuries or illnesses have not yet been reported in the source text.
Plain-English summary
Philips Healthcare is recalling 50 units of the InnerCool RTx Endovascular System, specifically Model Numbers 861470 (120V) and 861472 (240V). The device is a thermal regulating system intended to induce, maintain, and reverse mild hypothermia, achieve normothermia, and reduce fever. The recall covers units distributed nationwide in the United States and internationally to Austria, France, Germany, The Netherlands, Spain, Sweden, and Switzerland.
The recall was initiated because the device's Main Control Board (MCB) may produce an inaccurate low patient temperature reading and a low temperature alarm. This defect could result in incorrect temperature monitoring for patients using the system.
Healthcare facilities and users should stop using the affected devices and contact Philips Healthcare for further instructions on the recall process.
The recalled product
- 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 redu
- Manufacturer
- Philips Healthcare
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Numbers: 861470 (120V)
- 861472 (240V).
Distribution
Distributed nationwide across the United States.
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