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.
