Reported Aug 12, 2015 · Terminated
ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers:…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045
Is this the product you have?
- ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD
- biopsy guidelines 6C1HD - model numbers
10442008 6C1HD Needle GuideS300010440586 6C1 HD Biopsy Guide
- S2000 18L6 - model numbers
10442007 18L6 Biopsy GuideS3000 10044200 S2000 Biopsy Starter Kit18L6 HD 10855189 18L6 HD Biopsy Starter Kit
- S1000 RadiologyThe ultrasound imaging systems are
- intended for the following applicationsFetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications
- Lot codes and dates
- 6C1HD -
- model numbers
10442008 6C1HD Needle GuideS300010440586 6C1 HD Biopsy GuideS200018L6
- model numbers10442007 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
- Amount recalled
- 4140 total
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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