Severity
Moderate
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. 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. The system also provides the ability to
Reported: July 8, 2015 Initiated: May 29, 2015 #Z-1959-2015 573 devices units
Siemens Medical Solutions USA, Inc. issued this FDA Devices recall on July 8, 2015. Classified as Moderate severity (Class II). Approximately 573 devices units are affected. The recall was issued because: When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some select…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1959-2015) was formally reported on July 8, 2015, with the manufacturer initiating the action on May 29, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc. is listed as the recalling firm, operating out of Mountain View, CA. Federal records indicate 573 devices units are affected.
The documented reason for this recall is: When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia, Czech Republic, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
573 devices
Related Recalls
6
6 from same agency
Product Description
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. 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. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Reason for Recall
When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 573 devices
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lithuania, Malaysia, Maldives, Mauritius, Mexico, Netherlands, Nigeria, Oman, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed, San Marino, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom and Venezuela
- Location
- Mountain View, CA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1959-2015 |
| Date reported | July 8, 2015 |
| Date initiated | May 29, 2015 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Units affected | 573 devices |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia, Czech Republic, Ecuador, Egypt, Finl… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. 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. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 573 devices.
Why was this product recalled? ▼
When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1959-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lithuania, Malaysia, Maldives, Mauritius, Mexico, Netherlands, Nigeria, Oman, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed, San Marino, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom and Venezuela.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1959-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).