Agency classClass IOur severity:Severe FDA (Devices)·Z-0748-2013·Announced 2013-02-20

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly."

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
Category: Medical Device — Resuscitation Equipment
Hazard: assembly-defect
functional-failure

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

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 →

Same manufacturer · GE Healthcare, LLC

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