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U.S. Department of Health and Human Services

Class 3 Device Recall Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata,

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  Class 3 Device Recall Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, see related information
Date Initiated by Firm October 16, 2003
Date Posted December 03, 2003
Recall Status1 Terminated 3 on August 25, 2004
Recall Number Z-0175-03
Recall Event ID 27661
510(K)Number K020991  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
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.
Code Information Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and 7106557.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.
FDA Determined
Cause 2		 Other
Action The recalling firm field representatives are visiting each location to correct the problem through a software upgrade.
Quantity in Commerce 118 units
Distribution The products were shipped nationwide to hospitals and medical imagining centers.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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