GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob
GE Healthcare is recalling 48 Stand-Alone Resuscitation Units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device for infant resuscitation) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare is recalling 48 units of the Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612. The recall is due to a potential defect where the adjustment knob may be loose, which could affect the accuracy of the blended Air/Oxygen gas mixture provided to patients.
The affected units are distributed worldwide, including the United States (nationwide), Puerto Rico, and numerous international locations. The specific serial numbers for the recalled units are listed in the official recall documentation.
Healthcare facilities and consumers should stop using the affected units and contact GE Healthcare for further instructions or replacement. The device provides basic equipment required for pulmonary resuscitation of infants.
The recalled product
- Product
- Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
- Manufacturer
- GE Healthcare
- Affected units
- 48
Distribution
Part of a larger recall action
This product is one of 6 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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