CLASS II Device recall · Reported 12 Aug 2015 · FDA Enforcement Report

Acuson S Family ultrasound systems utilizing the 18L6 HD recalled

Siemens Medical Solutions USA is recalling Acuson S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines, distributed nationwide in the US. The recall was initiated on 29 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000; 18L6 model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter Kit, S1000 See Consignee list for all serial numbers.

Quantity recalled4140 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2344-2015
FDA event ID: 71697
Recalling firm: Siemens Medical Solutions USA, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2015
FDA classified: 5 Aug 2015
Reported: 12 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

29 Jun 2015	Recall initiated by company
5 Aug 2015	Classified by FDA	+37 days
12 Aug 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the on-screen guidelines.

Product as listed by the FDA

ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000 18L6 - model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter Kit, S1000 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.

Where it was distributed

Worldwide Distribution - US Nationwide and the countries of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Dem. Rep. Congo, Denmark, Dominican Rep., Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Venezuela and Vietnam.

Nationwide

Questions about this recall

Why was it recalled?

When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the on-screen guidelines.

Which lots are affected?

6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000; 18L6 model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter Kit, S1000 See Consignee list for all serial numbers.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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