Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
This recall has been terminated (originally issued December 19, 2006).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- November 17, 2006
- Posted
- December 19, 2006
- Terminated
- November 19, 2008
- Recall Number
- Z-0302-2007
- Quantity
- 23,345 units - 4336 US
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
Model numbers 4715319, 5206110, 5732388, and 7489375.
Root Cause
Other
Action Taken
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.
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