Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 8/27/03
Class: II
PRODUCT
a) MR Systems. Recall # Z-1087-03;
b) Leonardo Workstations with software version 2022A/B,
2003A. Recall # Z-1088-03;
c) Leonardo Workstations with software versions prior to
2022A. Recall # Z-1089-03.
REASON
Software problem. This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
CODE
a) Upgrade Harmony Syngo MR, model 7106714 K2200, Serial
# 10501 through 10587.
Harmony Syngo MR, model 7104693 K2200, Serial # 11001
through 11172.
Upgrade Symphony Syngo MR, model 7106557 K2210, Serial
# 14001 through 14321.
IMPACT – Upgrade Syngo MR (MU3S), model 5751438 K2220,
Serial # 15001 through 15030.
IMPACT – Upgrade Syngo MR (MU3L), model 7106466 K2220,
Serial # 15501 through 15519.
VISION – Upgrade Quantum, model 4772971 K2230 Serial #
16001 through 16017.
VISION – Upgrade Sonata, model 7388148 K2230 Serial #
16501 through 16513.
Concerto Upgrade, model 7106995 K2221 Serial # 17201
through 17211.
Concerto, model 4772906 K2221 Serial # 17301 through
17473.
Syngo Allegra, model 7106433 K2183 Serial #20101 through
20110.
Upgrade Allegra syngo MR, model 7387736 K2183 Serial
# 20401 through 20421.
Trio (Bruker), model 7106441 K2180 Serial #20500 through
20507.
Trio, model 7387074 K2180 Serial #20510 through
20524 and 20550 through 20552.
Sonata Syngo MR, model 7104719 K2240 Serial #21101
through 21248.
Syngo MR SYM-Sonata-Upgrade, model 7104735 K2240 Serial
#21604 through 21612.
Syngo MR Upgrade Sonata, model 7106425 K2240 Serial
#21901 through 21942.
Symphony syngo MR, model 7104594 K2210 Serial 22001
through 22996.
Rhapsody, model 7384568 K2190 Serial # 24001 through
24004.
b) Model 7129534, Serial # 01001 through 01380, 05001
through 05600, and 10001 through 10320;
c) Model 7129534, Serial #01001 through 01380, 05001
through 05600, and 10001 through 103320.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated February 28, 2003, March 01, 2003, and April 14, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,374 units.
DISTRIBUTION
Nationwide.
