Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 28, 2019
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal a
The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc. recalled ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medica… - a moderate-severity action.
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medica… was recalled by Siemens Medical Solutions USA, Inc. in August 28, 2019. Reason: The action is being initiated due to internal testing which identified a possibility for transducers to excee…. Check the official notice for the remedy. Verify recall #Z-2353-2019 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall-The action is being initiated due to internal testing which identified a possibility for transducers to excee….
- Moderate
- severity level
- Class II
- classification
- August 28, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2353-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2353-2019) was formally reported on August 28, 2019, with the manufacturer initiating the action on January 28, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Medical Solutions USA, Inc. is listed as the recalling firm, operating out of Mountain View, CA. Federal records list the affected scope as 2262 systems.
The documented reason for this recall is: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculat… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL,IA, IN, KY, LA, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA,…. 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
2262 systems
Related Recalls
6
3 from same agency
Product description
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Reason for recall
The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2353-2019 |
| Date reported | August 28, 2019 |
| Date initiated | January 28, 2019 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Firm location | Mountain View, CA |
| Affected scope | 2262 systems |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL,IA, IN, KY, LA, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY; and … |
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-2353-2019) 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 NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 2262 systems.
Why was this product recalled? ▼
The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2019. Severity: Moderate. Recall number: Z-2353-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL,IA, IN, KY, LA, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY; and countries of: Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mexico, Morocco, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Philippines, Poland, Portugal, Republic of Korea, Romania, Ruanda, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, U.A.E., Uganda, Ukraine, United Kingdom, Uruguay, Uzbekistan and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2353-2019) 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 28, 2019. 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.