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Penlon

PENLON LTD · Model Prima 450 · UDI-DI 05051977000000

BSZ Prescription

510(k) clearances

47,945

Adverse events (112 deaths)

173

Recalls

Facilities

Recalls

Date	Firm	Reason
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
2025-10-20	Mindray DS USA, Inc. dba Mindray North America	Potential for anesthesia leakage.
2025-10-20	Mindray DS USA, Inc. dba Mindray North America	Potential for anesthesia leakage.
2025-09-09	Draeger, Inc.	The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2025-09-09	Draeger, Inc.	The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

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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.