Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Reason for recall: Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered. Distribution: Worldwide - US Nationwide distribution in the states of Colorado, Massachusetts, New Mexico, New Hampshire and the countries of Algeria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Austria, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Kenya, Korea, Republic of, Kuwait, Lithuania, Mexico, Netherlands, Nor Quantity: 902 units Lot/code info: Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
07340153700109, 07340153700116
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.