Recall Z-0443-2014 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products Inc
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.
| Date | Dec 4, 2013 (initiated May 15, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Cincinnati Sub-Zero sent a Urgent Medical Device Notification letter dated July 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They instructed their customers to to do the following: 1) Upon receipt of the corrected Blanketrol III Data Export Software disc, immediately collect and destroy all previous Blanketrol III Data Export Software disc from this lot # currently in possession and replace all downloaded Blanketrol III Data Export Software with the correct version provided by CSZ. 2) After the Blanketro |
| Quantity | 12 Units |
| Distribution | Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.