Laurel, MD, United States
Ohmeda Medical recalls
2 recalls recorded since 2018, most recently on 5 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 5 October 2018
- Terminated
- 2 June 2020
- 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.
- Distribution
- Worldwide distribution- Domestic nationwide and foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0041-2020
- 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
Terminated Class II Medical devices
- Recall started
- 1 December 2017
- Terminated
- 17 September 2019
- Reason
- There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
- Distribution
- USA (nationwide)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1181-2018
- Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.