Z-0932-2015Class II

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

Name: Z-0932-2015 Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform...
Creator: Baxter Healthcare Corp.
Published: 2014-04-24
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-04-24 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis on 2014-04-24. FDA classified it as Class II and gives the reason as "System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0932-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-24
Posted: 2015-01-07
Terminated: 2017-07-21
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
Product code: FKX System, Peritoneal, Automatic Delivery
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.
FDA root cause: Under Investigation by firm
Action: Baxter sent an IMPORTANT PRODUCT INFORMATION letter dated April 24, 2014 to all affected customers. The peritoneal dialysis provider consignees were instructed to: 1) complete the enclosed customer reply form and return it to Baxter; and, 2) contact Baxter Technical Services at 800-553-6898 should a System Event 01179 occur. Baxter Technical Services is available 24 hours a day, 7 days a week. Clinical questions can be directed to Baxter's Renal Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00 PM CT). General questions regarding the Import Product Information letter can be direct to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CT). For questions regarding this recall call 800-422-9837.
Quantity in commerce: 55 units
Distribution: Nationwide Distribution including GA, MA, NC, NY, PA, and WA.
Product codes and lots: Product Code: 5C9310

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0932-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0932-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07

Product code FKX

K124018Class IIAmia Automated Pd SystemDeka Research & Development Corp. / cleared 2013-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)