ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.

FDA device recall Z-1667-2014 · posted 2014-05-28 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.

Action taken

Siemens sent an Customer Safety Advisory Notification letter on April 23, 2014, to all affected customers. Distributors in foreign countries will implement delivery of notification to their customers. " Use the factory default presets with software version 3.5 instead of user-defined presets restored from software version 2.0 or 3.0. 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. " After adjusting the Doppler frequency, freeze and unfreeze the system. This action refreshes the display of the Doppler spectrum resulting in accurate measurements. Additional measurements performed after system freeze results in correct measurement values. Your local Customer Service Engineer will contact you to schedule an appointment to replace your existing version of software, free of charge. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the new software has been installed on your system, please share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a high priority, and we alert customers of product concerns which may occur under various conditions. To date, no patient injury has been reported as a result of these issues. We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions call (650) 694-5398.

Root cause

Software design

Status

Terminated

Product code

IYN

Quantity affected

257 units

Distribution

Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, LS, MD, MI, MN, MO, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI., and the countries o

Date initiated

2014-04-23

Date posted

2014-05-28

Date terminated

2015-11-12

Location

Mountain View, CA

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