Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 13, 2015
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: 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 measur
In some cases, the system is unable to capture a clip or image during a routine scan.
Siemens Medical Solutions USA, Inc. recalled ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA1… - a moderate-severity action.
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA1… was recalled by Siemens Medical Solutions USA, Inc. in May 13, 2015. Reason: In some cases, the system is unable to capture a clip or image during a routine scan.. Check the official notice for the remedy. Verify recall #Z-1581-2015 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall-In some cases, the system is unable to capture a clip or image during a routine scan..
- Moderate
- severity level
- 186 units
- affected scope
- Class II
- classification
- May 13, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1581-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1581-2015) was formally reported on May 13, 2015, with the manufacturer initiating the action on May 11, 2012. 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 186 devices.
The documented reason for this recall is: In some cases, the system is unable to capture a clip or image during a routine scan. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kaza…. 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
186 devices
Related Recalls
6
3 from same agency
Product description
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: 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. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;
Reason for recall
In some cases, the system is unable to capture a clip or image during a routine scan.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1581-2015 |
| Date reported | May 13, 2015 |
| Date initiated | May 11, 2012 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Firm location | Mountain View, CA |
| Affected scope | 186 devices |
| Distribution | Worldwide Distribution - US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kazakhstan, Kenya, Kuwai… |
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-1581-2015) 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 SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: 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. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 186 devices.
Why was this product recalled? ▼
In some cases, the system is unable to capture a clip or image during a routine scan.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2015. Severity: Moderate. Recall number: Z-1581-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kazakhstan, Kenya, Kuwait, Mauritius, Mexico, Norway, Oman, P.R. China, Poland, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1581-2015) 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 May 13, 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.