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Terminated

ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

FDA Recall Z-2783-2015 · Posted 2015-09-17

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2015-08-19
Date Terminated2017-10-19
Product Quantity2039 devices

Reason for Recall

The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.

Firm Action

Siemens sent a Customer Safety Advisory Notification letter on August 19, 2015 by certified mail. The letter identified the affected product, problem and actions to be taken. The letter states that this issue will be resolved in a future software release. If you have any questions,please contact your customer care center 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 who need to be aware of this issue. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries.

Root Cause

Software design

Distribution Pattern

Worldwide distribution. US Nationwide and the countries of Albania, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Hungary,, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

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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