Reported Jul 8, 2015 · Terminated
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045
Is this the product you have?
- ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option
- Model number 10433816The SC2000 ultrasound imaging system is
- intended for the following applicationsCardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes
- Lot codes and dates
- Model number 10433816 between
- software version VA16A and VA30AUS
- Serial numbers
152 of 152 codes
400930401216401375401343401049400538401115400572400464401346400196401030401246400222400455400457401090401078400318401345400668400667401158400545401022401184401308401141401311400462400467400460400461401383400466401149401300400479400493400519400861400117401070400907400740400552400454401204400530400814400818400835400900400810400811401155401156400736401279401280
- ROW serial numbers
421 of 421 codes
400935400604400682400597400833400140400753401016400166400582400983401036400784400919401376401159400186400499400896400809401160400774400282400758400723401532400402400633400296400111400319400515400942400793400343400849401400400816401143400216400212400713400215400730400734401021400920401140401239401128401052400815400766401133401018400729400731400213400903401334
- Amount recalled
- 573 devices
Why it was recalled
When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
This product could cause temporary or reversible health problems — stop using it.
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