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VORTRAN Medical Air Compressor

VORTRAN MEDICAL TECHNOLOGY 1, INC · Model 8100 · UDI-DI 10637320081005

BTI Prescription
1
510(k) clearances
8,170
Adverse events (37 deaths)
5
Recalls
72
Facilities

Description

The VORTRAN Medical Air Compressor is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital uses. It is capable of servicing nebulizer and humidifiers to product particle aerosol mist.

Recalls

DateFirmReason
2023-12-29Datex-Ohmeda, Inc.GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/
2023-12-29Datex-Ohmeda, Inc.GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/
2023-12-29Datex-Ohmeda, Inc.GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/
2013-12-05Maquet Cardiovascular Us Sales, LlcMaquet Compressor Mini may deliver compressed air at a temperature higher than specified.
2007-01-26Draeger Medical, Inc.Compressors not providing sufficient supply pressure to connected medical ventilator

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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.