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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc.
- Reason for Recall:
- In certain situations, loss of post exercise images can occur in Stress Echo.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1584-2015
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