Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglob
FDA device recall Z-0802-2013 · posted 2013-02-12 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- 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.
- Action taken
- Terumo sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 1, 2010 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions or concerns.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DRY
- Quantity affected
- 622 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2010-11-01
- Date posted
- 2013-02-12
- Date terminated
- 2013-11-08
- Location
- Ann Arbor, MI
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