XiO RTP System. Used to create treatment plans for any recall
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Why was XiO RTP System. Used to create treatment plans for any recalled?
When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
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?
MUJ
- Product
- XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
- Recalling firm
- Elekta, Inc.
- Quantity
- 1424
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, QA, WA, WV, WI, and WY, and the countries of Albania, Algeria, Argentina, Austria, Australia, Bosnia, Bulgaria, Belgium, Bahrain, Brazil, Belarus, Botswana, Bangladesh, Canada, China, Columbia, Costa Rica, Croatia, Cuba, Cyprus, Chile, Czech Republic, Ecuador, Egypt, Estonia, France, Finland, Gabon, Germany, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Italy, Ireland, Israel, Iraq, Jordan, Japan, Kosovo, Kuwait, Lithuania, Libya, Latvia, Morocco, Malaysia, Malta, Mexico, Myanmar, Netherland, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sudan, Syria, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, Venezuela, and Vietnam.
- Recall date
- February 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)