Segmented Cylinder Applicator Set recall
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate…
Why was Segmented Cylinder Applicator Set recalled?
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387
- Product
- Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate…
- Recalling firm
- Varian Medical Systems, Inc.
- Quantity
- 21 devices
- Distribution
- Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
- Recall date
- May 22, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)