FDA Device recall Z-0993-2022
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
- FDA Device
- Class II
- ongoing
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 by Baxter Healthcare, citing 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 Lim….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0993-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-15 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Reason
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.
Identifiers
| code_info | a) 955558, UDI 07332414124359, b) 955627, UDI 07332414124700, c) 955701, UDI 07332414125844, All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0993-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.