Recall Z-0288-04 ยท FMZ Incubator, Neonatal
Ohmeda Medical, A Div of Datex-Ohmeda , Inc
Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
| Date | Jul 20, 2004 (initiated Oct 17, 2003) |
| Status | Terminated |
| Reason | Heater vent door on neonatal incubator may malfunction. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1404 beds |
| Distribution | Products were sold to 365 direct accounts around the US and 58 international distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED Ohmeda Medical, May 9, 2002 |