Z-0993-2022Class II

PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

Name: Z-0993-2022 PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Creator: Baxter Healthcare Corporation
Published: 2022-03-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-03-15 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 on 2022-03-15. FDA classified it as Class II and gives the reason as "This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0993-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-15
Posted: 2022-04-22
Recalling firm: Baxter Healthcare Corporation
Product: PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: The firm notified its consignees be letter on 03/15/2022. The following instructions were provided: "1. Operators may continue to safely use the PrisMax System. To ensure patient safety, there are two approaches to address the anomalies: Approach 1: Choose new patient at every filter set change. This will require re-input of all prescription settings and therapy will begin without prescription settings and treatment data from the previous filter set. Approach 2: Choose Same Patient when changing a filter set. Check and correct the Gain/Loss Limit or RDL prior to starting treatment. See Attachment A to change the Gain/Loss Limit See Attachment B to change the RDL The device should only be used by a trained operator per the instructions in the Operator s Manual. Please ensure that every operator of this device is made aware of this Urgent Medical Device Correction. 2. When the software upgrade becomes available, a local Baxter representative will contact your facility to determine the correction plan and schedule the upgrade for impacted devices. Your facility will be receiving this upgrade from Baxter at no charge. 3. Acknowledge the receipt of this notification by completing a reply form on the customer portal."
Quantity in commerce: 3513 units
Distribution: Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Product codes and lots: a) 955558, UDI 07332414124359, b) 955627, UDI 07332414124700, c) 955701, UDI 07332414125844, All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0993-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0991-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-22
Z-0992-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-22
Z-0993-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-22

Product code KDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)