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Codonics Safe Label System®(SLS) 500i Point of Care Station

CODONICS INC. · Model 500i PCS · UDI-DI 00814905020229

BSZ Prescription

510(k) clearances

49,196

Adverse events (113 deaths)

177

Recalls

Facilities

Description

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items

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.