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ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM

PARKER-HANNIFIN CORPORATION · Model 40151617 · UDI-DI 00816711020165

BSZ

510(k) clearances

48,583

Adverse events (113 deaths)

177

Recalls

Facilities

Description

INTL DMDM BASIC ASSY,30 CANADA

Recalls

Date	Firm	Reason
2026-07-30	Datex-Ohmeda, Inc.	Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 10
2026-07-30	Datex-Ohmeda, Inc.	Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 10
2026-07-30	Datex-Ohmeda, Inc.	Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 10
2026-07-30	Datex-Ohmeda, Inc.	Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 10
2026-06-24	Maquet Critical Care AB	Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient
2026-05-07	Draeger, Inc.	The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2026-05-07	Draeger, Inc.	The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2025-11-14	GE Medical Systems China Co., Ltd.	Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of
2025-11-14	GE Medical Systems China Co., Ltd.	Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of
2025-11-14	GE Medical Systems China Co., Ltd.	Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.