Device product
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Z-1917-2025
Product summary
- Event
- Event 96849
- Status
- Completed
- Classification
- Class II
- Quantity
- 6517 cases total
- Official record key
device-enforcement:Z-1917-2025
Official wording
Reason: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Code information: UDI-DI (GTIN) 10885380186516 (EA) 50885380186514 (BX) ALL LOTS
Distribution pattern: Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Derived failure modes
-
Device software or design
software logic may cause frequent E1 errors (system high pressure). Issue