Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physio
FDA device recall Z-0939-2013 · posted 2013-03-11 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.
- Action taken
- Drager sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-543-5047 for questions relating to this notice.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 260
- Distribution
- Distributed in the states of CA, IL, and MA.
- Date initiated
- 2012-12-13
- Date posted
- 2013-03-11
- Date terminated
- 2013-05-20
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET (K113798) | Draeger Medical Systems, Inc. | 2012-03-22 |
| INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION (K093788) | Draeger Medical Systems, Inc. | 2010-03-08 |