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Terminated

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.

FDA Recall Z-0175-03 · Posted 2003-12-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2003-10-16
Date Terminated2004-08-25
Product Quantity118 units

Reason for Recall

Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.

Firm Action

The recalling firm field representatives are visiting each location to correct the problem through a software upgrade.

Root Cause

Other

Distribution Pattern

The products were shipped nationwide to hospitals and medical imagining centers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020991SYNGO MR 2002BSiemens Medical Solutions USA, Inc. · 2002-06-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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