FDA Device recall Z-1875-2017
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C
- FDA Device
- Class II
- terminated
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class II recall of 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1875-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-30 |
| Published | 2017-05-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | US serial numbers: 200113 200245 200394 200695 200706 200715 200935 201159 201256 201916 202076 202551 202…US serial numbers: 200113 200245 200394 200695 200706 200715 200935 201159 201256 201916 202076 202551 202559 202584 202587 202600 202626 202937 203212 205736 205850 206286 206919 206949 207048 207073 207087 207096 207099 207551 207552 207560 207566 207572 207648 207713 208114 208142 208153 208984 209481 210012 210017 210061 210128 210143 210157 210163 210173 210188 210241 210274 210324 210334 210439 210508 210569 210584 210664 210665 210666 210679 210703 210735 210737 210742 210744 210747 210753 210811 210832 210861 210873 210979 210981 211018 211026 211070 211093 211124 211138 211158 211167 211244 211249 211302 211316 211325 211335 211336 211337 211338 211340 211347 211352 211354 211355 211357 211362 211375 211460 211480 211499 211513 211549 211581 211626 211627 211637 211639 211643 211647 211648 211649 211650 211653 211659 211666 211715 211717 211720 211723 2117 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1875-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.