CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturati
FDA device recall Z-2610-2011 · posted 2011-06-22 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the values displayed by the CDI"101 Hematocrit/Oxygen Saturation Monitoring System: hematocrit (HCT), hemoglobin (Hgb) and Oxygen Saturation.
- Action taken
- Terumo Cardiovascular Systems, Corp issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 28, 2011, to all affected customers. The letter identifed the product, the problem and the action needed to be taken by the customer. After a solution has been verified, Terumo CVS will implement a correction for all affected units. Customers were instructed to review this Medical Device Correction notice, Assure that all users are aware of this notice. Confirm receipt of this and to fax back the Customer Response form. For further question please contact Terumo CVS Customer Service at 1-800-521-2818, Monday - Friday, 8 AM - 6 PM EST.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DRY
- Quantity affected
- 622
- Distribution
- Worldwide Distribution -- USA ( nationwide) and the countries of Colombia, Vietnam, India, Indonesia, Pakistan, Canada, Chile, Vietnam, Chile, Hong Kong, United Arab Emirates, Singapore, Australia, Ma
- Date initiated
- 2011-04-28
- Date posted
- 2011-06-22
- Date terminated
- 2012-11-06
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDI (TM) SYSTEM 100 MONITORING SYSTEM (K902654) | 3M Health Care, Ltd. | 1990-11-05 |