Device product
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Z-1531-2016
Product summary
- Event
- Event 73744
- Status
- Terminated
- Classification
- Class I
- Quantity
- 370 units
- Official record key
device-enforcement:Z-1531-2016
Official wording
Reason: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Code information: Product Code 710200L, Serial Number Range 200318 -203922 distributed between 08/05/2013 - 07/07/2014.
Distribution pattern: Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI
Derived failure modes
-
Unknown
Potential leakage of conductivity sensors of the Dialog Dialysis machines.