Product Wiki · Recalls · Health Canada — Medical Devices

ACUSON ULTRASOUND SYSTEMS (2015-07-02) — recall 53950

Health Canada — Medical Devices · Canada · 2015-07-21 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
53950
Date of alert
2015-07-21
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: To notify users of the ACUSON family ultrasound systems of a recent finding regarding needle guides. Two Transducers, 6C1 HD and 18l6 HD demonstrate misalignment while utilizing the on-screen guidelines. The issue occurs when using the CIVCO Biopsy attachments in combination with the ACUSON family on-screen guidelines. The biopsy needle may traverse outside the on-screen guidelines. This occurs on the 6c1 HD and 18l6 HD Transducers.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/acuson-ultrasound-systems-2015

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