Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
FDA device recall Z-0288-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Ohmeda Medical, A Div of Datex-Ohmeda , Inc
- Reason for recall
- Heater vent door on neonatal incubator may malfunction.
- Action taken
- The recalling firm notified domestic consignees by certified letter and international distributors by e-mail dated 10/17/2003. The recall notice was incorporated into a firm''s follow-up letter concerning an on-going product correction of the elevating base on the same neonatal beds. The letter advises of the malfunctioning heater door vent and states that the firm will replace all existing vent doors with doors made of higher temperature rated material. Firm will provide retrofit kits for consignee or service representative installation.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMZ
- Quantity affected
- 1404 beds
- Distribution
- Products were sold to 365 direct accounts around the US and 58 international distributors.
- Date initiated
- 2003-10-17
- Date posted
- 2004-07-20
- Date terminated
- 2005-10-11
- Location
- Laurel, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OHMEDA MEDICAL GIRAFFE OMNIBED (K020543) | Ohmeda Medical | 2002-05-09 |