Z-0175-03

Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo...

Name: Z-0175-03 Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo...
Creator: Siemens Medical Solutions USA, Inc
Published: 2003-10-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-10-16 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata... on 2003-10-16. The reason FDA records is "Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0175-03
Status: Terminated
Initiated: 2003-10-16
Posted: 2003-12-03
Terminated: 2004-08-25
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.
FDA root cause: 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.
Product codes and lots: Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and 7106557.

Product code LNH

K020991Class IISyngo Mr 2002BSiemens Medical Solutions USA, Inc. / cleared 2002-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)