Terumo CDI 500 Blood Parameter Monitoring System Recalled for Inaccurate Readings
Terumo is recalling 4,638 CDI 500 Blood Parameter Monitoring Systems worldwide due to inaccurate readings of vital blood parameters following a software upgrade to version 1.69.
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 where inaccurate readings of vital parameters pose a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 4,638 units of the CDI 500 Blood Parameter Monitoring System. This medical device provides continuous, on-line monitoring of extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin, and temperature.
The recall is due to inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings that occurred following a software upgrade to version 1.69. The affected units are identified by model codes 500A, 500AHCT, 500AV, and 500AVHCT.
The affected devices were distributed worldwide, including nationwide in the United States (including DC, PR, and all states) and in numerous international countries such as Australia, Canada, Japan, and the United Kingdom. Healthcare facilities and users of these monitoring systems should verify their software version and contact the manufacturer for instructions on corrective action.
The recalled product
- Product
- CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 4,638
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 (5)
- 500A
- 500AHCT
- 500AV
- 500AVHCT CDI Blood Parameter Monitoring System 500
- software version 1.69.
Distribution
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