Recall Z-2291-2019 ยท ILO Pack, Hot Or Cold, Water Circulating
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.
| Date | Jul 19, 2019 |
| Status | Terminated |
| 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 |
| Quantity | 2079 units |
| Distribution | Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.