Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.
FDA Recall Z-3055-2011 · Posted 2011-08-22
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Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeJAQ
Date Initiated2011-07-13
Date Terminated2012-06-20
Product Quantity1019 total
Reason for Recall
Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.
Firm Action
Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs customers to locate old design applicator probes and guiding tubes and to cease use of the affected products. Information in the letter included instructions on how to return the products to Varian BrachyTherapy.
Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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