Cincinnati Sub-Zero Recalls Blanketrol III Data Export Software Version 1.10
Cincinnati Sub-Zero Products Inc is recalling 12 units of Blanketrol III Data Export Software Version 1.10 because the wrong software version was released to a customer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software versioning error without reporting any specific injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity recall.
Plain-English summary
Cincinnati Sub-Zero Products Inc is recalling 12 units of Blanketrol III Data Export Software Version 1.10. The software is intended for the electronic transfer of medical device data from the Blanketrol III to a computer without controlling or altering the function or parameters of the device.
The recall was initiated after a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, revealed that the wrong software version had been released to a customer. The affected units are identified by Product/Part #86127, Catalog #USB-127, and Lot #00554.
The recalled software was distributed worldwide, including in the United States (Alaska, Colorado, Florida, Massachusetts, Michigan, and North Carolina) and internationally to Canada, Germany, and the United Kingdom. Consumers and healthcare facilities should stop using the affected software and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- Cincinnati Sub-Zero Products Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product/Part #86127
- Catalog #USB-127
- Lot #00554
Distribution
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