Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Reported: February 20, 2013 Initiated: November 1, 2010 #Z-0802-2013
Product Description
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Reason for Recall
Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 622 units
- Distribution
- Worldwide Distribution.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 622 units.
Why was this product recalled? ▼
Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2013. Severity: Moderate. Recall number: Z-0802-2013.
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