Siemens AG Medical Engineering Class III

Company: Siemens AG Medical Engineering
Date of Enforcement Report: 3/27/02
Class: III

PRODUCT
a) ACOM.PC Angiographic X-ray System;
b) Digital Image Communications System.
Recall # Z-0603-2.

REASON
Software problem in recording heights and weights.

CODE

Siemens part number:
a) ACOM.PC V3.0-4371105
b) Quantcor V4.0-4786898, 5915553, 5915579.
Equipment Concerned:

Product: Part No. Serial No.

LVA V 4.0 single station 47 86 898 >=01439
LVA V 4.0 1x Floating 59 15 553 all
LVA V 4.0 3x Floating 59 15 561 all
LVA V 4.0 6x Floating 59 15 579 all
LVA V 4.0 10x Floating 59 15 587 all
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter in April 2001.
Manufacturer: Siemens AG Medical Engineering, Forcheim, Germany.
Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
34.

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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