Venturi Ventilator Class II 1 units

Venturi Ventilator, provides a software that continuously adaptsto the patient’s changing breathing demands and assures
ventilation at the lowest pressure. Recall #Z-803-9.

REASON

Software error may cause ventilator to deliver more than set
tidal volume.

CODE

Venturi Ventilator with Software Revision C. Serial #970222.

MANUFACTURER

Cardiopulmonary Corporation, Milford, Connecticut.

RECALLED BY

Manufacturer, by letter on May 18, 1998. Firm-initiated recall
complete.

DISTRIBUTION

England.

QUANTITY

1 unit was distributed.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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