Z-0850-2019Class II

Kaguya Automated Peritoneal Dialysis System

Name: Z-0850-2019 Kaguya Automated Peritoneal Dialysis System
Creator: Baxter Healthcare Corporation
Published: 2018-12-11
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-12-11 / Terminated / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal... on 2018-12-11. FDA classified it as Class II and gives the reason as "Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0850-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-11
Posted: 2019-02-20
Terminated: 2021-02-12
Recalling firm: Baxter Healthcare Corporation
Product: Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Root cause tag: software
FDA root cause: Software design
Action: Baxter Healthcare Corporation notified providers on about 12/11/2018 of the recall concerning the AMIA Automated Peritoneal Dialysis System, via "Urgent Medical Device Correction" letter. Patients were notified on about 1/14/2018 via "Urgent Medical Device Correction" letter. Providers were instructed to continue using the AMIA Automated PD System however, for patients who are prescribed a Cycle-Based therapy, to change these therapies to Time-Based by following the programming instructions within the Clinician Guide, Section 5.3.1 - Time-Based Programming Method. In Time-Based therapy, to maintain a fixed dwell time, the Smart Dwell treatment option needs to be Disabled. To disable the Smart Dwell treatment option, follow the programming instructions within the Clinician Guide, Section 5.3.1 - Time-Based Programming Method. Questions can be directed to Baxter's Renal Clinical Helpline at 888-736-2543, option 2, Monday through Friday, 8:00 am to 4:30 pm (CT). Providers were informed that Baxter would contact them when the software update is available and provide further instructions on how to download the upgrade remotely. They were also instructed to complete and return the Baxter Customer Reply Form and to inform customers if the device was further distributed to other facilities or departments within their institution. Patients were instructed to continue using the AMIA Automated PD System however, they were directed to check the Programming Method to ensure they have not been prescribed Cycle-Based therapy. The programming method can be verified by following section 10.3 of the Patient Guide: 1. touch "GO" on the home screen and the Confirm Treatment screen should appear, 2. touch "Program Settings" to view the program settings details and the Program Details screen will appear, 3. display the "Program Method" by navigating to Page 3 by pressing the down arrow at the bottom of the screen. If the Programming Method is Time-Based or Tidal, the iss
Quantity in commerce: 1,085 devices
Distribution: Worldwide Distribution - US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Canada and Japan.
Product codes and lots: Product code T5C8500. All serial numbers are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0850-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0849-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-20
Z-0850-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-20

Product code FKX

K151525Class IIAmia Automated PD System with SharesourceDeka Research and Development / cleared 2015-10-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)