May

2017

Cl II 18L6 HD transducer on the ACUSON S

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/3/2017
Class lI:

PRODUCT

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C;Model numbers:18L6 HD transducer 10041227 & 10789400S1000 10441701S2000 10041461S2000 (Refurb) – 10440017S3000 10441730Radiology
Recall Number Z-1875-2017

REASON
When scanning with the 18L6 HD transducer on the ACUSON HELX” Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View CA on 3/30/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,045 systems

DISTRIBUTION
Nationwide and Intenrationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II 18L6 HD transducer on the ACUSON S

Amy Sellers

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