PrisMax System — Class II medical device recall Z-0992-2022
Ongoing recall by Baxter Healthcare Corporation, reported 2022-05-04, distributed nationwide. This correction is due to software anomalies occurring during use. If the operator initiates therapy by enteri
| Recall number | Z-0992-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-03-15 |
| Classified | 2022-04-22 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, DE, DK, EE, ES, FI, FR, GB, GR, HK, IE, IL, IT, JM, KR, MX, NL, NO, NZ, PL, PT, SA, SE, SG, TR, TT, VN |
| Quantity | 296 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07332414126018 |
Product
PrisMax System, Product Code 955724
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0992-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.