FDA Device recall Z-0824-2014
ACUSON SC2000 Ultrasound System
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of ACUSON SC2000 Ultrasound System by Siemens Medical Solutions Usa, citing the user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0824-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-22 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
Reason
The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.
Identifiers
| code_info | Model number 10433816; Serial numbers lower than 401100. Serial numbers: 400935 400686 400597 400833 400140 400…Model number 10433816; Serial numbers lower than 401100. Serial numbers: 400935 400686 400597 400833 400140 400753 400752 400771 401016 400166 400635 400582 400983 400532 400580 400592 400804 400733 400737 400652 401036 400643 400746 400349 400784 400919 400685 400777 400186 400499 400896 400809 400259 400282 400758 400762 400831 400723 400402 400633 401027 400111 400319 400515 400942 400793 400699 400849 400816 400216 400212 400713 400764 400730 400734 401021 400215 400735 400920 401052 400815 400766 401018 400729 400731 400213 400903 400254 400670 400560 401048 401056 400280 400722 400945 400405 400407 400546 400975 400904 400982 400980 400151 400961 400941 400325 400562 401073 400242 400415 400952 400732 400444 400149 400543 400661 400547 400726 400939 400510 401050 400243 400779 401072 400106 400147 400173 400302 400347 400348 400453 400553 400557 400558 400995 4009 |
|---|
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-0824-2014%22
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