The Recall Desk
HighFDA (Devices)·Z-0723-2018·Announced 2018-03-07

Elekta Agility with Integrity R3.2 Software Recall for Positional Errors

Elekta Limited is recalling Agility with Integrity R3.2 software due to a potential for positional errors following automatic table movement.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for positional errors, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Elekta Limited is recalling 539 units of Agility with Integrity R3.2 software. The recall was initiated because of a potential for positional errors following automatic table movement (ATM). The product code is 90I--YE, and no serial numbers are associated with the recall.

The affected software was distributed domestically to numerous U.S. states and territories, including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. It was also distributed internationally to a wide range of countries, including Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, Venezuela, Vietnam, and Zimbabwe.

The source text does not specify instructions for consumers or healthcare providers on how to respond to this recall. No illnesses, injuries, or deaths are reported in the source text.

The recalled product

Product
Agility with Integrity R3.2
Manufacturer
Elekta Limited
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
539

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product code 90I--YE
  • no serial numbers

Distribution

Distributed in 48 states:

Part of a larger recall action

This product is one of 2 recalled by Elekta Limited under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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