Stabilet Infant Warming System, model numbers 200, 300… recallZ-1955-2009 · Draeger Medical Systems, Inc. · initiated Jul 17, 2009
Terminated All recalls posted in August 2009
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 Systems, 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
Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.
FDA root cause category: Equipment maintenance
What the company is doing
On 7/20/09, Draeger Medical, the recalling firm, issued a press release to medical media outreach organizations and an Urgent Medical Device letter to all known customers. This information explained the incident and the need to remove and replace the units in question as soon as feasibly possible.
Recall details
- Recall number
- Z-1955-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 17, 2009
- Posted by the FDA
- Aug 25, 2009
- Recalling firm
- Draeger Medical Systems, Inc.
- Quantity
- 6489 units
- Product code
- FMT
- FDA submissions
- K042607, K850069, K913945
- Distribution
- Worldwide distribution: USA, Brazil, Canada, China, Dominican Republic, France, Korea, Lebanon, Mexico, Nigeria, Panama, Poland, Saudi Arabia, Taiwan, Turkey, United Kingdom, Uruguay, and Venezuela.
Product description
Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
Code information (models, lots, serial numbers)
All units of model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
Other devices under the same FDA submission
1 device cleared under K042607, K850069, K913945 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Apollo 8606500Drägerwerk AG & Co. KGaA · Gas-Machine, Anesthesia90 reports
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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