Device product
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Z-1031-2015
Product summary
- Event
- Event 70232
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200
- Official record key
device-enforcement:Z-1031-2015
Official wording
Reason: The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Code information: all codes distributed between 4/15/2014 and 6/11/2014
Distribution pattern: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and District of Columbia
Derived failure modes
-
Unknown
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.