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Z-0932-2015 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0932-2015 was initiated by Baxter Healthcare Corp. on Apr 24, 2014 and is designated Class II. Reason for recall: System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger. The recall status is terminated (terminated Jul 21, 2017). Affected quantity: 55 units.

Recall Details

Product Type: Devices
Report Date: Jan 14, 2015
Initiation Date: Apr 24, 2014
Termination Date: Jul 21, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 55 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Product Code: 5C9310

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0932-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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