Terminated

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.

FDA Recall Z-2344-2015 · Posted 2015-08-05

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeIYN

Date Initiated2015-06-29

Date Terminated2018-01-18

Product Quantity4140 total

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.

Firm Action

Siemens sent a Customer Safety Advisory Notification letters to affected customers via certified mail with return receipt. The letter identified the affected product, problem, potential risk to patients and actions to be taken. Seimens instructed that this notice be shared with all personnel within your organization who need to be aware of this issue. For questions contact your Siemens service representative.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.