The Recall Desk

FDA (Devices) recall action 60480

Terumo Cardiovascular Systems Corporation recalled 5 products on 2013-07-24

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2013-07-24
Critical
0
Units
—

Why these products were recalled

Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System for Software Error

    Terumo is recalling the CDI 500 Blood Parameter Monitoring System due to software algorithm inaccuracies. A software update is being developed to correct the issue.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hema
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error

    Terumo is recalling the CDI 500 Blood Parameter Monitoring System because software inaccuracies were found in the algorithm. A software update is being developed to correct the issue.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, he
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error

    Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because a software algorithm inaccuracy was discovered during internal testing.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desi
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Inaccuracies

    Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because software inaccuracies may affect monitoring during cardiopulmonary bypass.

    Product
    CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desire
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring Systems

    Terumo is recalling CDI 500 Blood Parameter Monitoring Systems because software contains unused accuracy correction factors for hematocrit and saturation calculations.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperatur
    Category
    Distribution
    49 states