ACUSON SC2000 ultrasound systems model 10433816 Imaging system that… — Class II medical device recall Z-0182-2016
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-11-04, distributed in GA. Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware
| Recall number | Z-0182-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Mountain View, CA, United States |
| Recall initiated | 2015-10-07 |
| Classified | 2015-10-28 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2017-10-19 |
| Distributed | GA |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, LB, LT, MT, MX, MY, NG, NL, NO, NZ, PH, PK, PL, PT, RO, RS, SA, SE, SG, SK, SV, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 2,099 units |
| Reason classes | software |
| Serial numbers | 400023, 400024, 400029, 400043, 400048, 400050, 400063, 400065, 400066, 400067, 400069, 400070, 400081, 400084, 400086, 400087, 400088, 400090, 400093, 400100, 400101, 400102, 400106, 400108, 400111 and 475 more |
| Model numbers | 10433816 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0182-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.