FDA-Device2013-02-20Class II
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Terumo Cardiovascular Systems Corporation
Hazard
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.
Sold states
Worldwide Distribution.
Affected count
622 units
Manufactured in
6200 Jackson Road, Ann Arbor, MI, United States
Products
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0802-2013Don't want to check this manually?
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