Agency classClass IOur severity:Severe FDA (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.

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 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: assembly-defect
respiratory-risk

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 →

Same manufacturer · GE Healthcare, LLC

See all →

High
GE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
High
GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
High
GE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
High
GE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
Severe
GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27

Same hazard · assembly defect