FDA Device recall Z-1056-2015
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the follo…
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the follo… by Siemens Medical Solutions Usa, citing the bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1056-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-12 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | GA |
Product
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. 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 bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.
Identifiers
| code_info | Model number 10433816. serial numbers 401100 to 401400. |
|---|
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-1056-2015%22
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