Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 5, 2015
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral posi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc. recalled ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model… - a moderate-severity action.
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model… was recalled by Siemens Medical Solutions USA, Inc. in August 5, 2015. Reason: Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ reg…. Check the official notice for the remedy. Verify recall #Z-2321-2015 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall-Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ reg….
- Moderate
- severity level
- 629 units
- affected scope
- Class II
- classification
- August 5, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2321-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2321-2015) was formally reported on August 5, 2015, with the manufacturer initiating the action on June 25, 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 list the affected scope as 629 units.
The documented reason for this recall is: Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not ali… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., France, Germany, Greece, Hong Kong, In…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
629 units
Related Recalls
6
3 from same agency
Product description
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Reason for recall
Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2321-2015 |
| Date reported | August 5, 2015 |
| Date initiated | June 25, 2015 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Firm location | Mountain View, CA |
| Affected scope | 629 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., France, Germany, Greece, Hong Kong, India, Indonesia, Isra… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2321-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 629 units.
Why was this product recalled? ▼
Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2015. Severity: Moderate. Recall number: Z-2321-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2321-2015) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 5, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.