- Recalling firm
- Gentherm Medical, LLC
- Reason for recall
- Overheating of the 115V CPU board may cause the device to shut down.
- Affected products (lot / model / serial)
- UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
- Units affected
- 182 units
- Distribution pattern
- Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.
- Firm location
- Blue Ash, OH, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2968-2026
- Recall initiated
- July 13, 2026
- FDA classification date
- August 14, 2026
- FDA report date
- August 26, 2026
- FDA event ID
- 99478
- Last updated on HTM Vibe
- September 8, 2026