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
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