Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity… recallZ-0302-2007 · Draeger Medical, Inc. · initiated Nov 17, 2006
Terminated All recalls posted in December 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0302-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 17, 2006
- Posted by the FDA
- Dec 19, 2006
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 23,345 units - 4336 US
- Product code
- MHX
- FDA submissions
- K053484
- Distribution
- Nationwide
Product description
Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
Code information (models, lots, serial numbers)
Model numbers 4715319, 5206110, 5732388, and 7489375.
Other devices under the same FDA submission
1 device cleared under K053484 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INFINITY GAMMMA XL MS18985Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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