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Siemens Medical Solutions USA, Inc. recalls 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 1
Recalled May 3, 2017 · FDA recall Z-1875-2017 · Siemens Medical Solutions USA
Hazard
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. · FDA Class II
Units
2,045 systems
Sold at
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates, Argentina, Armenia, Austria, Australia, Azerbaijan, Bahrain,Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Ethiopia, Egypt, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Venezuela, Vietnam and United Kingdom,
Description
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.
Product
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →