Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 12/24/03
Class: II
PRODUCT
Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade. Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and 7106557. Recall # Z-0175-03.
REASON
Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.
CODE
Software version VA21C.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by visit starting on October 16, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
118 units.
DISTRIBUTION
Nationwide.
