Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system.
FDA Recall Z-2468-2008 · Posted 2008-09-29
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2008-08-05
Date Terminated2010-12-21
Product Quantity2541 units
Reason for Recall
As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.
Firm Action
The firm initiated its field correction on 08/05/2008. The firm's service personnel will make site visits to correct the problem and install the revised software (version 1.5.0c). Contact Siemens Medical Solutions USA, Inc. at 1-650-694-5993 for assistance.
Root Cause
Software design
Distribution Pattern
Worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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