Elekta Monaco - Product Usage: used to make treatment recall
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Why was Elekta Monaco - Product Usage: used to make treatment recalled?
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002190(10) 5.40.01, (01)00858164002190(10) 5.40.02, (01)00858164002268(10) 5.51.10
- Product
- Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Recalling firm
- Elekta Inc
- Quantity
- 214 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia.
- Recall date
- October 6, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)