Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
FDA device recall Z-1051-2008 · posted 2008-03-18 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.
- Action taken
- The firm notified consignees on 2/1/08, by an Important Safety Notice. The letter instructed users to remove any units from use until a Draeger Service Representative can replace the power board. A Service Representative will be in contact to schedule a service visit. For questions concerning this recall please contact 215-660-2418 or Anbu.arasu@draeger.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FMZ
- Quantity affected
- 18 units
- Distribution
- Worldwide Distribution-- USA including states MO, OH, and PR, and countries of Australia, Canada, Columbia, Israel, UAE, France, China, Italy, Denmark, Switzerland, and UK.
- Date initiated
- 2008-01-31
- Date posted
- 2008-03-18
- Date terminated
- 2008-05-08
- Location
- Telford, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL TI500 ISOLETTE INFANT INCUBATOR (K941106) | Air-Shields, Inc. | 1994-06-10 |