Draeger Infinity Acute Care System Monitoring Solution
FDA device recall Z-0714-2014 · posted 2014-01-10 · Terminated
Recall details
- Recalling firm
- Draeger Medical Systems, Inc.
- Reason for recall
- After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
- Action taken
- An Urgent Medical Device Recall Letter, dated December 2013, was sent to Users. Once available Drager will update components of the IACS Monitoring Solution System.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 439
- Distribution
- US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
- Date initiated
- 2013-12-10
- Date posted
- 2014-01-10
- Date terminated
- 2015-05-20
- 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 |