Public recall detail

Prismax and Thermax Systems

2025-08-06

medium
Recall Safety notice
Quick summary

Quick summary: Prismax and Thermax Systems. Date: 2025-08-06.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Prismax and Thermax Systems. Date: 2025-08-06.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBaxter Healthcare Sa
ProductPrismax and Thermax Systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77814

Affected products

ProductThermax Blood Warmer Units
LotAll lots.
Model955515
Serial numberAll lots.
DescriptionThermax Blood Warmer Units
ProductPrismax Systems
LotAll lots.
Model955558
Serial numberAll lots.
DescriptionPrismax Systems
ProductPrismax Systems
LotAll lots.
Model955725
Serial numberAll lots.
DescriptionPrismax Systems

Issue

Vantive is issuing an urgent medical device correction due to the following three issues: Prismax system alarm T2309: air detected in prime may be raised after priming with a low liquid level in the deaeration chamber. The system correctly detects the presence of air within the disposable set and raises the alarm at the end of priming if the condition is present. Users should follow the on-screen instructions to reprime the disposable set. Prismax system alarm T0830: blood leak detected may be raised when no blood leak is present, or the operator may have difficulty normalizing the blood leak detector (BLD) leading to Prismax system alarms T1313: BLD normalize failed, T0853: normalization failed, or T1205: BLD self-test failure. Operators should follow the on-screen instructions and return the blood in the disposable set if connected to a patient. Thermax system may be unable to detect the presence of a bag on the Thermax blood warmer unit leading to difficulty setting up therapy, or Prismax system alarm T2284: Thermax disposable not inserted. Operators should follow the on-screen instructions and return the blood in the disposable set if connected to a patient. Recall start date: July 28, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology Health products - Medical devices - Haematology
CompaniesBaxter Healthcare Sa Thurgauerstrasse 130, Glattpark (Opfikon), Switzerland, 8152
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77814
Background{}
CompaniesBaxter Healthcare Sa Thurgauerstrasse 130, Glattpark (Opfikon), Switzerland, 8152
AudiencesHealthcare
Source updated2025-08-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...