Recall Z-0182-2016 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
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.
| Date | Oct 30, 2015 (initiated Oct 7, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 2,099 units |
| Distribution | 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, Fr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123622 | ACUSON Siemens Medical Solutions USA, Inc., Dec 5, 2012 |