9 results
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32ms
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Sources: EU EUDAMED, US FDA
PANDA IRES WARMER
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code FMT·November 22, 2022
PANDA IRES WARMER
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code FMT·September 24, 2025
PANDA IRES WARMER
FDA Adverse Event
Injury
·DATEX-OHMEDA, INC.·Product code FMT·December 1, 2025
PANDA IRES WARMER
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code FMT·April 13, 2023
PANDA IRES WARMER
FDA Adverse Event
Injury
·DATEX-OHMEDA, INC.·Product code FMT·July 3, 2024
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 2, 2013
PANDA IRS
FDA Adverse Event
Injury
·DATEX-OHMEDA, INC.·Product code BTL·August 15, 2023
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BTL·June 26, 2012
Obelis s.a.
Authorized representative
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