BEUDAMED
    22 results · 40ms · Sources: EU EUDAMED, US FDA

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    Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G 115/230V SERVO2 CARESTATION, ASSY-LAU, OMNIBED CHINA EBASE S HUMID, Manufacturing assembly - Make, OBSOLETE-Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/CE Plug, ASSY-LAU, Omnibed Czech S-PH w/Nist O2 w/Reus Probe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Czech S-PH w/Reusable Probe CE Power Cord, Finished good - Make, Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/Ce Plug, ASSY-LAU, Omnibed Indonesian S-GR W/Reuseable Probe CE Plug, Finished good - Make, ASSY-LAU, Omnibed ENG S-Gr w/REUProbe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Portuguese S-PH w/NIST O2w/Reusable Probe CE Power Cord, Finished good - Make. Incubator, Neonatal, Warmer, Infant radiant

    FDA Recall
    Open, Classified ·DATEX--OHMEDA, INC.·Product code FMZ·May 19, 2023

    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

    FDA Recall
    Open, Classified ·Datex-Ohmeda Inc·Product code FMT·May 8, 2026

    Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    EVair air compressor, model numbers: M1230849 and M1230847

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Beside panel FRU (Field Replacement Units) Kits

    FDA Recall
    Open, Classified ·DATEX--OHMEDA, INC.·Product code FMZ·May 19, 2023

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator

    FDA Recall
    Open, Classified ·DATEX--OHMEDA, INC.·Product code FMZ·September 3, 2024

    Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

    FDA Recall
    Open, Classified ·Datex-Ohmeda Inc·Product code FMT·May 8, 2026

    Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650-0082-902, 6650-0061-902, 6650-0131-902, 6650-0034-902, 6650-0104-902, 6650-0066-902, 6650-0042-902, 6650-0143-901, 6650-0148-902, 6650-0152-901, 6650-0107-902, 6650-0136-902, 6650-0060-902, 6650-0056-902, 6650-0043-902. Labeled as OMNIBED ENG EBASE S-HUMID, GIRAFFE OMNIBED, GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, OMNIBED SW EBASE S-HUMID, Giraffe OmniBed Legacy, OMNIBED FR EBASE S-HUMID, OMNIBED GR EBASE S-HUMID, OMNIBED SP EBASE S-HUMID, ASSY-LAU, OMNIBED ENG EBASE S-HUMI D, Finished good - Make, OBSOLETE-OMNIBED UK EBASE S-HUMID, OMNIBED UK EBASE S-HUMID. Incubator, Neonatal

    FDA Recall
    Open, Classified ·DATEX--OHMEDA, INC.·Product code FMZ·May 19, 2023

    EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    GE Heathcare Giraffe OmniBed; neo natal incubator

    FDA Recall
    Open, Classified ·DATEX--OHMEDA, INC.·Product code FMZ·September 3, 2024

    Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code QSF·July 12, 2024

    Amingo. OUS only.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code N/A·July 12, 2024

    EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance

    FDA Recall
    Open, Classified ·Datex-Ohmeda Inc·Product code BTM·May 8, 2026