The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1733-2013·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device used during critical surgical procedures where inaccurate monitoring could lead to patient harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. The recall involves 3,972 units that were distributed worldwide, including the United States, Canada, Australia, Japan, and other countries. The devices are intended for use during cardiopulmonary bypass procedures to continuously monitor arterial and venous blood parameters such as pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature.

The recall was initiated after Terumo discovered through its own testing that the system's software contains inaccuracies associated with a software algorithm. A software update has been developed to address this issue, and a premarket notification (K130425) has been submitted to the FDA. Terumo will implement the update once clearance is received from the agency.

Affected units are identified by catalog number 500A* and specific serial numbers listed in the recall notice. Healthcare facilities and users should contact Terumo Cardiovascular Systems Corporation for instructions on how to obtain the software update.

The recalled product

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…
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Blood Monitoring
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Catalog number: 500A* and serial numbers: 1211
  • 1559-1563
  • 1663-1666
  • 1722-1727
  • 1754-1758
  • 1776
  • 1795
  • 1951
  • 1952
  • 2016
  • 2112
  • 2117
  • 2190
  • 2246
  • 2273
  • 2274
  • 2322
  • 2355
  • 2356
  • 2389-2391

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

See all →

Same hazard · software error

See all →

Similar recalls