22
Sep
2004

Inc. Class II Siemens Medical Solutions USA

0

Company: Siemens Medical Solutions USA, Inc..
Date of Enforcement Report: 9/22/04
Class: II

PRODUCT
Axiom Sensis Report Workstation. Recall # Z-1446-04.

REASON
Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.

CODE
Serial Numbers 1002, 1034, 1100-1253, 1300-1504.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by a Customer Safety Advisory on May 17, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
234 units.

DISTRIBUTION
Nationwide.

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.

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