Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 11/3/04
Class: II
PRODUCT
a) AXIOM Sensis Programmable diagnostic computer, Model number
66 23 974. Recall # Z-0032-05.
b) AXIOM Sensis Programmable diagnostic comp uter, Model number
66 34 633. Recall # Z-0033-05;
c) AXIOM Sensis Programmable diagnostic computer, Model number
66 34 641. Recall # Z-0034-05;
d) AXIOM Sensis Programmable diagnostic computer, Model number
66 34 658. Recall # Z-0035-05;
e) AXIOM Sensis Programmable diagnostic computer, Model number
66 48 161. Recall # Z-0036-05.
REASON
Possible error calculating valve area with the AXIOM Sensis.
CODE
a) Serial numbers: 1155, 6002, 6006-6014, 6016, 6018-6021,
6023-6025, 6027-6053, and 6100-6125. Model number 66 34 641
involves the following serial numbers: 4001-4008 and 4050-
4056. Model number 66 34 658 involves the following serial
numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055.
Model number 66 48 161 involves the following serial numbers:
11001-11014, 11016, 11018, and 11050-11054;
b) Serial numbers: 2001-2011, 2013-2023, 2025-2026, 2028,
2031-2067, 2069-2090, 2092-2132, 2134-2143, 2145-2148,
2150-2158, 2160-2260, 2262, and 2265-2266;
c) Serial numbers: 4001-4008 and 4050-4056;
d) Serial numbers: 8001-8003, 8006-8007, 8009-8010, and
8050-8055.
e) Serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter, on July 9, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
143 units.
DISTRIBUTION
Nationwide.
