Device product
Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.
Z-0443-2014
Product summary
- Event
- Event 66632
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 Units
- Official record key
device-enforcement:Z-0443-2014
Official wording
Reason: During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer.
Code information: Product/Part #86127, Catalog #USB-127, Lot #00554
Distribution pattern: Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.
Derived failure modes
-
Unknown
During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer.