Device product
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
Z-2136-2026
Product summary
- Firm
- DJO, LLC
- Event
- Event 98638
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 480
- Official record key
device-enforcement:Z-2136-2026
Official wording
Reason: Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Code information: Model/Catalog Number: 11-1424 Lot Code: Lot: 110525 GTIN: 00888912017305
Distribution pattern: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.
Derived failure modes
-
Unknown
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.