Integrity 3.0 Product Usage: The Agility multileaf recall
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation…
Why was Integrity 3.0 Product Usage: The Agility multileaf recalled?
Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
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?
325134, 325254, 325082, 325159, 325268, 325237, 325331, 325267, 325236, 325314, 325127, 325261, 325286, 325077, 325269, 325129, 325296, 325273, 325139, 325201, 325137, 325184, 325161, 325076, 325086, 325112, 325081, 325083, 325099, 325110, 325271
- Product
- Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation…
- Recalling firm
- Elekta, Inc.
- Quantity
- 31
- Distribution
- USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico
- Recall date
- June 5, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)