Recall Z-0802-2013— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2010-11-01, terminated 2013-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.. Reason: 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..
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2010-11-01
- Terminated
- 2013-11-08
- Firm location
- Ann Arbor, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.