FDA Recalls MICRO-TEMP LT Heat Therapy Systems Due to Tissue Damage Risk
Cincinnati Sub-Zero is recalling 2,079 MICRO-TEMP LT heat therapy systems because updated warnings indicate that exceeding 40°C for extended periods may cause tissue damage.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Cincinnati Sub-Zero Products LLC, a Gentherm Company, is recalling 2,079 units of the MICRO-TEMP LT System, Model 749. This localized heat therapy system is intended to warm a patient's body part through conductive heat transfer. The recall covers serial numbers 141-LT-02789 through 193-LT-05137 and UDI 10613031881165.
The recall was initiated because updated manual warnings state that exceeding 40°C for extended periods may cause tissue damage. The agency has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected units were distributed nationwide and in foreign countries including Australia, Canada, Chile, Colombia, Guatemala, Israel, Japan, the Netherlands, Poland, Singapore, South Korea, and the United Arab Emirates. Users should stop using the device and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
- Hazard
- Affected units
- 2,079
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 (1)
- Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165
Distribution
Distributed nationwide across the United States.
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