Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

Reason: 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.

Code information: Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.

Distribution pattern: 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, Norway, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.