GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings
GE Healthcare is recalling 276 Giraffe and Panda T-Piece Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.
What this means for you
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 involves a medical device used for infant resuscitation with a functional defect (reversed fittings) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling 276 units of the Giraffe and Panda T-Piece Resuscitation System. These devices provide basic equipment for pulmonary resuscitation of infants. The recall affects specific model numbers including M1139417, M1223628, and various M1192226 series units.
The recall was initiated because the oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. This manufacturing error could affect the device's ability to deliver the correct gas mixture during emergency resuscitation.
The affected units were distributed worldwide, including in the United States and countries such as Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland, and the United Kingdom. Users should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
- Manufacturer
- GE Healthcare, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Models M1139417
- M1223628
- M1192226-072951
- M1192226-084200. M1192226-095181
- M1192226-104599
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC 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.
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