ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. ...
FDA Device Recall #Z-1584-2015 — Class II — July 11, 2012
Recall Summary
| Recall Number | Z-1584-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 11, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc. |
| Location | Mountain View, CA |
| Product Type | Devices |
| Quantity | 476 |
Product Description
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. 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.
Reason for Recall
In certain situations, loss of post exercise images can occur in Stress Echo.
Distribution Pattern
Worldwide Distribution -- US and Albania, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, P.R. China, Philippines, Portugal, Rep. of Yemen, Republic Korea, Russian Fed., San Marino, Saudi Arabia, Singapore, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, and Venezuela.
Lot / Code Information
Serial Numbers: 400935 400140 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733 400737 400746 400752 400753 400771 400777 400784 400833 400919 400499 400896 400809 400296 400111 400319 400793 400699 400849 400816 400213 400212 400215 400251 400254 400407 400560 400670 400713 400722 400729 400730 400731 400734 400764 400766 400815 400920 400945 400149 400289 400341 400444 400510 400547 400562 400575 400732 400779 400904 400936 400939 400980 400987 401009 400321 400549 400922 400125 400199 400200 400043 400755 400808 400926 400426 400756 400806 400950 400424 400566 400711 400727 400801 400834 400911 400927 400933 400827 400127 400637 400642 400205 400880 400690 400745 400778 400802 400240 400591 400432 400780 400785 400819 400824 400825 400826 400838 400842 400844 400845 400863 400869 400871 400910 400937 400938 400724 400846 400973 400219 400300 400158 400159 400172 400181 400182 400187 400191 400192 400211 400249 400250 400279 400298 400301 400339 400512 400544 400579 400588 400590 400688 400738 400739 400741 400798 400812 400761 400837 400841 400850 400655 400839 400870 400879 400917 400578 400278 400423 400563 400606 400769 400901 400116 400165 400178 400214 400262 400266 400274 400275 400271 400414 400420 400430 400616 400760 400823 400876 400915 400928 400934 400253 400403 400412 400498 400581 400728 400765 400189 400897 400924 400908 400796 400836 400840 400946 400948 400957 400963 400218 400277 400856
Other Recalls from Siemens Medical Solutions USA, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3217-2024 | Class II | ACUSON Maple 1.0 Diagnostic Ultrasound System, ... | Aug 15, 2024 |
| Z-3215-2024 | Class II | ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ul... | Aug 15, 2024 |
| Z-3216-2024 | Class II | ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasoun... | Aug 15, 2024 |
| Z-1599-2024 | Class II | ACUSON Juniper Diagnostic Ultrasound System, RE... | Feb 23, 2024 |
| Z-1601-2024 | Class II | ACUSON Maple Diagnostic Ultrasound System, REF:... | Feb 23, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.