Terminated

ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.

FDA Recall Z-0182-2016 · Posted 2015-10-30

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeIYN

Date Initiated2015-10-07

Date Terminated2017-10-19

Product Quantity2,099 units

Reason for Recall

Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock becomes disconnected, and where the system locks up due to misalignment between the bezel and MPI board, in all units that have not already been corrected.

Firm Action

On August 19, 2015, Siemens Ultrasound began sending a customer notification to users, advising them to correct the uppercase/lowercase differences in the patient name at the time of registration until the issue is resolved with a future software release. Siemens believed that the other issues in this correction will begin approximately November 30, 2015 and December 31, 2015. Field service reps will visit sites to install software updates or hardware corrections.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- US and 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, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mexico, Netherlands, New Zealand, Nigeria, Norway, P.R. China, Pakistan, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, 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.