ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
FDA Recall Z-1668-2014 · Posted 2014-05-28
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2014-04-23
Date Terminated2015-11-12
Product Quantity177 units
Reason for Recall
Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.
Firm Action
Siemens sent a Consumer Safety Advisory Notification letter on April 23, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the stress echo feature with software version .5. For studies acquired with systolic-only captures: review all patient studies on exams performed after software revision 3.5 was installed on your system. If you are unsure when this software was installed on your system,
please contact your local Customer Service representative. Foreign distributors will implement distribution of the field correction to their customers.
For questions regarding this recall call 650-694-5398.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belarus, Dominican Rep., France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Republic of Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, U.A.E., Ukraine, and United Kingdom.
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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