FDA Medical Device Recalls (openFDA)
Draeger Medical Systems, Inc.: Draeger Infinity Acute Care System Monitoring Solution
- Recall number
- Z-0714-2014
- Recalling firm
- Draeger Medical Systems, Inc.
- Product
- Draeger Infinity Acute Care System Monitoring Solution
- Status
- Terminated
- Initiated
- 2013-12-10
- Posted
- 2014-01-10
- Terminated
- 2015-05-20
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 439
- Distribution
- US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
- Lot, serial or model codes
- with software versions VG2.0.3 and higher.
- 510(k) numbers
- ["K113798"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2510954
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28