Device product
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Z-1316-2023
Product summary
- Event
- Event 91776
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-1316-2023
Official wording
Reason: The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Code information: Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
Distribution pattern: US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
Derived failure modes
-
Unknown
The electrical safety testing was not properly performed on the impacted devices and additional testing is required