Recall Z-0802-2013 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
| Date | Feb 12, 2013 (initiated Nov 1, 2010) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 622 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.