FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
- Recall number
- Z-0302-2007
- Recalling firm
- Draeger Medical, Inc.
- Product
- Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
- Status
- Terminated
- Initiated
- 2006-11-17
- Posted
- 2006-12-19
- Terminated
- 2008-11-19
- Reason
- Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
- Root cause
- Other
- Action
- The recaling firm issued a recall letter to the US customers 11/17/2006 via certified mail. An authorized service representative will inspect each potentially affected unit. If a unit is found to have an affected docking station, the unit will be repaired or replaced free or charge. Notification to international customers will occur through the international subsidiaries.
- Quantity
- 23,345 units - 4336 US
- Distribution
- Nationwide
- Lot, serial or model codes
- Model numbers 4715319, 5206110, 5732388, and 7489375.
- 510(k) numbers
- ["K053484"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2517967
- 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