Reported May 22, 2013 · Terminated
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used…
Varian Medical Systems, 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: Varian Medical Systems, Inc. · 700 Harris St Ste 109 · Charlottesville, VA · 22903-4584
Is this the product you have?
- Segmented Cylinder Applicator Set, Model # GM11004150, when used for
- Pulsed Dose Rate (PDR) Product UsageUsage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer
- Lot codes and dates
Serial numbers H640383H640277H640384H640788H640D126H640385H640372H640303H640387
- Amount recalled
- 21 devices
Where it was sold
- Nationwide
Why it was recalled
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
This product could cause temporary or reversible health problems — stop using it.
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