FDA Device recall Z-0182-2016
ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation p…
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation p… by Siemens Medical Solutions Usa, citing 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 situati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0182-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-07 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | GA |
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
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.
Identifiers
| code_info | Serial Numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641…Serial Numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641 400770 401110 401114 401135 401136 401138 401169 401174 401176 401366 401370 401406 401460 401591 401750 401793 401803 402090 402139 402177 402197 402255 402323 402327 402339 402351 402387 402492 402508 402562 402566 400063 400066 400090 400261 400350 400763 400787 400789 400790 400791 400792 400794 400797 400881 400886 400888 400890 400892 400898 401957 402451 400139 400141 400171 400235 400287 400291 400292 400293 400337 400338 400351 400458 400459 400475 400526 400527 400529 400583 400589 400593 400620 400693 400720 400743 400843 400868 400872 400873 400877 400878 400891 400895 400921 400958 400959 400960 400970 400989 401001 401012 401029 401031 401041 401044 401065 401075 401081 401083 401130 401132 401175 401187 401237 401243 401271 401286 401291 401305 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0182-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.