Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 3, 2017
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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 Muscul
When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Medical Solutions USA, Inc. recalled 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A… - a moderate-severity action.
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A… was recalled by Siemens Medical Solutions USA, Inc. in May 3, 2017. Reason: When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound sy…. Check the official notice for the remedy. Verify recall #Z-1875-2017 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall-When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound sy….
- Moderate
- severity level
- Class II
- classification
- May 3, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1875-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1875-2017) was formally reported on May 3, 2017, with the manufacturer initiating the action on March 30, 2017. 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 2,045 systems.
The documented reason for this recall is: When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats o… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates, Argentina, Armenia, Austria, Australia, Azerbaijan, Bahrain,Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Col…. 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
2,045 systems
Related Recalls
6
3 from same agency
Product description
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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
When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1875-2017 |
| Date reported | May 3, 2017 |
| Date initiated | March 30, 2017 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Firm location | Mountain View, CA |
| Affected scope | 2,045 systems |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates, Argentina, Armenia, Austria, Australia, Azerbaijan, Bahrain,Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, C… |
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-1875-2017) 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? ▼
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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: 2,045 systems.
Why was this product recalled? ▼
When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 3, 2017. Severity: Moderate. Recall number: Z-1875-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates, Argentina, Armenia, Austria, Australia, Azerbaijan, Bahrain,Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Ethiopia, Egypt, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Venezuela, Vietnam and United Kingdom,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1875-2017) 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 3, 2017. 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.