Recall Z-0041-2020 ยท FMZ Incubator, Neonatal
Ohmeda Medical
Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on the
| Date | Oct 5, 2018 |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris. |
| Root cause | Labeling design |
| Action | On October 5, 2018, the recalling firm notified affected customers of the product issue via an Urgent Medical Device Correction letter. Customers were instructed to do the following: You can continue to use your Giraffe OmniBed systems in open Bed warmer mode and incubator mode. Care should be taken to achieve visible cleanliness during the cleaning process. Design of the Giraffe OmniBed allows for your facilities normal cleaning to be performed, following the step by step procedure to remove the canopy seal to reach visible debris accumulation. Contact your Biomedical department to perform t |
| Distribution | Worldwide distribution- Domestic nationwide and foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993407 | OHMEDA MEDICAL OMNIBED Ohmeda Medical, Jan 5, 2000 |