Synergy XVI Intended for radiation therapy treatment recall
Synergy XVI Intended for radiation therapy treatment.
Why was Synergy XVI Intended for radiation therapy treatment recalled?
XVI can incorrectly calculate the target position of the treatment table.
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?
XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1
- Product
- Synergy XVI Intended for radiation therapy treatment.
- Recalling firm
- Elekta, Inc.
- Quantity
- 380 US
- Distribution
- Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK.
- Recall date
- June 25, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)