Reported May 3, 2017 · Terminated
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6…
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?
- 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C
- Model numbers18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730
- RadiologyThe ultrasound imaging systems are
- intended for the following applicationsFetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications
- Lot codes and dates
- US serial numbers
988 of 988 codes
200113200245200394200695200706200715200935201159201256201916202076202551202559202584202587202600202626202937203212205736205850206286206919206949207048207073207087207096207099207551207552207560207566207572207648207713208114208142208153208984209481210012210017210061210128210143210157210163210173210188210241210274210324210334210439210508210569210584210664210665
- ROW Serial numbers
1,057 of 1,057 codes
200408200696200708202102202568202569203277205209206268206405206761207056207083208056208155208255210001210045210082210165210221210253210317210340210419210456210530210545210707210718210793210916211001211173211392211433211456211457211490211498211519211619211640211646211708211713211714211718211719211721211724211734211735211738211744211749211761211765211771211772
- US serial numbers
- Amount recalled
- 2,045 systems
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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