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Recall Observatory FDA recall evidence

Device product

Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

Z-0932-2015

April 24, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 69586
Status
Terminated
Classification
Class II
Quantity
55 units
Official record key
device-enforcement:Z-0932-2015

Official wording

Reason: System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

Code information: Product Code: 5C9310

Distribution pattern: Nationwide Distribution including GA, MA, NC, NY, PA, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.