Inc Class III Siemans Medial Solutions USA

Company: Siemans Medial Solutions USA, Inc Co
Date of Enforcement Report: 3/31/04
Class: III

PRODUCT
Acuson Cypress Echocardiography System. Catalog number 8264604; Recall # Z-0744-04.

REASON
Software problem – mode does not appear on screen.

CODE
Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292.

RECALLING FIRM/MANUFACTURER
Siemans Medial Solutions USA, Inc, Plymouth Meeting, PA, by telephone from February 22/16, 2004. Firm initiated recall in ongoing.

VOLUME OF PRODUCT IN COMMERCE
46 units.

DISTRIBUTION
Nationwide and Internationally.

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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