Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
FDA device recall Z-1955-2009 · posted 2009-08-25 · Terminated
Recall details
- Recalling firm
- Draeger Medical Systems, Inc.
- Reason for recall
- Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.
- Action taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- FMT
- Quantity affected
- 6489 units
- 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.
- Date initiated
- 2009-07-17
- Date posted
- 2009-08-25
- Date terminated
- 2011-06-01
- Location
- Telford, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMUS US (K042607) | Draeger Medical, Inc. | 2004-11-26 |
| STABILET INFANT RADIANT WARMER MODEL 2000C (K913945) | Hill-Rom, Inc. | 1992-02-12 |
| BORNING NEONATAL RESUSCITATOIN CENTER (K850069) | Borning Corp. | 1985-05-30 |