23
Oct
2002

Inc Class III Siemens Medical Systems

0

Company: Siemens Medical Systems, Inc
Date of Enforcement Report: 10/23/02
Class: III

PRODUCT
Somatom Sensation 16 systems.
Software upgrade from Somaris/5 VA50A to VA50B.
Recall # Z-0109-3.

REASON
Scans may be aborted if scans are started manually.

CODE
Model Number 7393114.
Four serial numbers 50012, 50022, 50025, 50029.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter in July 2002.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany.
Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4.

DISTRIBUTION
OH, NC and MA.

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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