XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Reported: October 28, 2015 Initiated: August 31, 2015 #Z-0130-2016
Product Description
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Reason for Recall
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 1440 units
- Distribution
- Worldwide Distribution-Domestic: AK, AL, AZ, CA, CO, CT, DC, FL, IN, IL, KY, MA, MD, MI, MN, MO, NJ, NC, ND, NY, OH, OK, PA, PR, TN, TX, VA, WA and WI; International: Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, France, Gabon, Germany, Greece, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Macedonia, Malaysia, Mali, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, The United Kingdom, Ukraine, Venezuela and Vietnam.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.. Recalled by Elekta, Inc.. Units affected: 1440 units.
Why was this product recalled? ▼
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2015. Severity: Moderate. Recall number: Z-0130-2016.
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