ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structure
FDA device recall Z-0182-2016 · posted 2015-10-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 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,
- Date initiated
- 2015-10-07
- Date posted
- 2015-10-30
- Date terminated
- 2017-10-19
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON (K123622) | Siemens Medical Solutions USA, Inc. | 2012-12-05 |