ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ACUSON SC2000 model number: 10433816; Stress Echo Feature model number: 1044966 Serial numbers - USA: 400290 400425 400439 400441 400443 400447 401176 400787 400789 400790 400791 400792 400794 400797 400063 400877 401187 401441 401590 401602 401638 400174 401612 401501 401507 401561 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400570 401010 401020 401235 401252 401564 401611 400998 400999 400979 401625 401631 400234 400312 400972 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400887 400889 401043 401257 401559 401576 400474 400902 400860 400875 400912 400925 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 400630 401558 401587 401644 400227 400473 400577 400649 401294 401600 ROW: 400652 400733 400737 400746 401437 401443 401478 401495 401650 400546 401506 401371 401325 401581 401620 401623 400302 400348 400347 400553 400558 400726 400995 400996 401120 401123 401209 401260 401338 401344 401442 401452 401551 401555 401556 401522 401560 401577 401579 401588 401589 401603 401604 401606 401643 401699 400125 400200 401434 401626 401615 400155 400180 400307 400704 401428 401541 401624 401004 401546 401519 401627 400247 400263 400511 401045 400497 400284 400252 401502 400655 400214 400253 400836 400840 401118 400218 400990 401127 401180.
- 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:
- Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.
- 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 with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
Product Codes/Lot Numbers:
ACUSON SC2000 model number: 10433816; Stress Echo Feature model number: 1044966 Serial numbers - USA: 400290 400425 400439 400441 400443 400447 401176 400787 400789 400790 400791 400792 400794 400797 400063 400877 401187 401441 401590 401602 401638 400174 401612 401501 401507 401561 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400570 401010 401020 401235 401252 401564 401611 400998 400999 400979 401625 401631 400234 400312 400972 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400887 400889 401043 401257 401559 401576 400474 400902 400860 400875 400912 400925 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 400630 401558 401587 401644 400227 400473 400577 400649 401294 401600 ROW: 400652 400733 400737 400746 401437 401443 401478 401495 401650 400546 401506 401371 401325 401581 401620 401623 400302 400348 400347 400553 400558 400726 400995 400996 401120 401123 401209 401260 401338 401344 401442 401452 401551 401555 401556 401522 401560 401577 401579 401588 401589 401603 401604 401606 401643 401699 400125 400200 401434 401626 401615 400155 400180 400307 400704 401428 401541 401624 401004 401546 401519 401627 400247 400263 400511 401045 400497 400284 400252 401502 400655 400214 400253 400836 400840 401118 400218 400990 401127 401180.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1668-2014
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