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Terumo Cardiovascular Systems Corporation recalls Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglob
Recalled February 20, 2013 · FDA recall Z-0802-2013 · Terumo Cardiovascular Systems
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. · FDA Class II
Units
622 units
Sold at
Worldwide Distribution.
Description
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.
Product
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →