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ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. ...

FDA Device Recall #Z-1668-2014 — Class II — April 23, 2014

Recall Summary

Recall Number Z-1668-2014
Classification Class II — Moderate risk
Date Initiated April 23, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc.
Location Mountain View, CA
Product Type Devices
Quantity 177 units

Product Description

ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.

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.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belarus, Dominican Rep., France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Republic of Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, U.A.E., Ukraine, and United Kingdom.

Lot / Code Information

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.

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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

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

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.

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