FDA Device recall Z-2783-2015
ACUSON SC2000 Ultrasound System with software versions VB10B and lower
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of ACUSON SC2000 Ultrasound System with software versions VB10B and lower by Siemens Medical Solutions Usa, citing the ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2783-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-19 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Reason
The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.
Identifiers
| code_info | Model 10433816: Serial numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495…Model 10433816: Serial numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641 400770 401110 401114 401135 401136 401138 401169 401174 401176 401370 401406 401366 401460 401591 401750 401753 401793 401803 402090 402139 402177 402197 402255 402323 402327 402339 402351 402387 402492 402508 400261 400350 400763 400787 400789 400790 400791 400792 400794 400797 400881 400886 400888 400890 400892 400898 400923 400951 400978 401023 401025 401957 402451 400090 400066 400063 400868 400873 401041 401540 402109 400139 400141 400171 400235 400287 400291 400292 400293 400351 400337 400338 400458 400459 400475 400526 400527 400529 400583 400589 400593 400620 400693 400743 400843 400872 400877 400878 400891 400895 400921 400958 400959 400960 400970 400989 401001 401012 401029 401031 401044 401065 401075 401081 401083 401130 401132 401139 |
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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-2783-2015%22
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