Dec

2003

Inc Class II Siemens Medical Solutions USA

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.

About the author

Amy Sellers

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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Inc Class II Siemens Medical Solutions USA

Amy Sellers

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