Z-0443-2014Class II

Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use...

Name: Z-0443-2014 Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2013-05-15
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2013-05-15 / Terminated / root cause: software

FDA source

Cincinnati Sub-Zero Products Inc began a recall of 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... on 2013-05-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0443-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Posted: 2013-12-04
Terminated: 2014-05-13
Recalling firm: Gentherm Medical, LLC
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.
Product code: DWJ System, Thermal Regulating
Reason for recall: 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 tag: software
FDA 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 Blanketrol Data Export Software Version 1.00 have been destroyed and downloaded versions replaced with version 1.10, complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that you have performed and completed the requested actions. Return the form by fax to (513) 772-9119 scan and e-mail the information to [email protected], or mail to: Cincinnati Sub-Zero 12011 Mosteller Road Cincinnati, OH 45241 U.S.A. For further questions please call 1-(800) 989-7373 or (513) 772-8810.
Quantity in commerce: 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.
Product codes and lots: Product/Part #86127, Catalog #USB-127, Lot #00554

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0443-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0443-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04

Product code DWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)