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Terminated

ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.

FDA Recall Z-0824-2014 · Posted 2014-01-24

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2013-12-22
Date Terminated2015-05-06
Product Quantity843 active units

Reason for Recall

The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.

Firm Action

Siemens sent an Customer Safety Advisory Notification letter on December 22, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to:. If you observe looseness in the attachment of the user interface module to the column on the ultrasound system, immediately stop using your system and contact your Siemens service representative for repair. Your local Customer Service Engineer will contact you to make the necessary repairs on your system. You will be contacted to schedule an appointment. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization will need to be aware of thls issue. As always, patient safety issues are a high priority, and we thus alert customers of product concerns which may occur undervarlous conditions. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions please call (650) 694-5398.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US (nationwide) and the countries of Albania, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Brunei, Canada, Columbia, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Israel, Italy, Japan, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, Norway, Oman, P.R. China, Philippines, Poland, Qatar, Rep of Yemen, Republic Korea, Romania, Russian Fed. San Marino, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. United Kingdom and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123622ACUSONSiemens Medical Solutions USA, Inc. · 2012-12-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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