FDA Device recall Z-1065-2018
ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Ne…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Ne… by Siemens Medical Solutions Usa, citing the application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiogra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1065-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-26 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ACUSON SC2000 Ultrasound System 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 application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.
Identifiers
| code_info | Software versions VB10A, VB10B, VB10D, VB10E that have PRIME license 11146943 and eSie PISA license 10439823. Serial…Software versions VB10A, VB10B, VB10D, VB10E that have PRIME license 11146943 and eSie PISA license 10439823. Serial numbers involved are: 400154 400173 400201 400252 400278 400294 400355 400423 400497 400518 400606 400614 400655 400761 400836 400840 400888 400899 400909 401173 401186 401195 401207 401230 401246 401254 401259 401289 401361 401367 401377 401423 401429 401443 401444 401451 401452 401454 401455 401491 401494 401501 401546 401561 401565 401567 401569 401572 401577 401580 401589 401603 401604 401606 401607 401612 401627 401643 401649 401654 401658 401661 401697 401699 401704 401711 401724 401731 401751 401757 401761 401762 401770 401775 401776 401784 401794 401807 401812 401815 401819 401823 401836 401844 401869 401876 401886 401887 401908 401910 401911 401921 401924 401962 401970 401993 402015 402018 402056 402061 402066 402067 402069 402071 402073 402075 402079 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1065-2018%22
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