The Recall Desk
HighFDA (Devices)·Z-0749-2013·Announced 2013-02-20

GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

GE Healthcare is recalling 276 Giraffe and Panda Bag and Mask 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 where a defect could compromise the delivery of oxygen or air. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 276 units of the Giraffe and Panda Bag and Mask Resuscitation System, Model M1139612. The recall affects 109 units distributed in the United States and the remaining units distributed worldwide in Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland, and the United Kingdom.

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 defect involves the basic equipment required for pulmonary resuscitation of infants.

Healthcare facilities and consumers who possess these devices should stop using them and contact GE Healthcare for instructions on how to proceed with the recall.

The recalled product

Product
Giraffe and Panda Bag and Mask 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
Category
Medical Device — Resuscitation Equipment
Hazard

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 (1)

  • Model M1139612

Distribution

Distributed in 31 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · assembly defect

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