The Recall Desk
HighFDA (Devices)·Z-0724-2018·Announced 2018-03-07

Elekta Integrity R1.2 Medical Device Recalled for Positional Error Risk

Elekta Limited is recalling 539 Integrity R1.2 units 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 is classified as FDA Class II and involves a risk-of-harm product (positional errors) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Elekta Limited is recalling 539 units of the Integrity R1.2 medical device. The recall is due to a potential for positional errors following automatic table movement (ATM). The product is identified by product code 90I--YE and has no serial number.

The affected units were 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. The devices were 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.

Healthcare facilities and users should contact Elekta Limited for further instructions regarding the recall. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Integrity R1.2
Manufacturer
Elekta Limited
Category
Medical Device — Radiation Therapy
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 number

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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