FDA Medical Device Recalls (openFDA)
Cincinnati Sub-Zero Products LLC, a Gentherm Company: MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
- Recall number
- Z-2291-2019
- Recalling firm
- Cincinnati Sub-Zero Products LLC, a Gentherm Company
- Product
- MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
- Status
- Terminated
- Initiated
- 2019-07-19
- Posted
- not on file
- Terminated
- 2020-05-13
- Reason
- Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
- Root cause
- Under Investigation by firm
- Action
- Gentherm issued an Urgent Medical Device Notification on 7/19/19 via UPS informing users of the problem, health risk and action to take :Immediately examine your inventory and update manual(s) subject to recall and ensure that obsolete manuals are removed from service In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. INSTRUCTIONS TO CUSTOMERS: 1) Access updated manuals and ensure that obsolete manuals are removed from service. Updated manuals maybe accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-0608.
- Quantity
- 2079 units
- Distribution
- Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
- Lot, serial or model codes
- Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILO
- Firm FEI
- 1516825
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28