Siemens ACUSON S Family Ultrasound Systems Recalled for Biopsy Guide Defect
Siemens is recalling ACUSON S Family ultrasound systems because biopsy needles may move outside the on-screen guidelines when using specific attachments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to procedural errors (needle traversing outside guidelines), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 4,140 ACUSON S Family ultrasound systems. The recall involves systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines, including specific model numbers for needle guides, biopsy guides, and biopsy starter kits. The affected units were distributed worldwide, including in the United States and numerous international markets.
The recall is due to a defect where, when using CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the on-screen guidelines. This issue could affect the accuracy of the biopsy procedure.
Healthcare providers and facilities with these systems should stop using the affected biopsy guidelines and contact Siemens Medical Solutions USA, Inc. for further instructions on the recall and corrective actions.
The recalled product
- Product
- 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 4,140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
Distributed nationwide across the United States.
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