CLASS II Device recall · Reported 12 Mar 2014 · FDA Enforcement Report

Desktop Pro TM linear accelerator control recalled by Elekta

Elekta is recalling Desktop Pro TM linear accelerator control, distributed nationwide in the US. The recall was initiated on 25 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesIdentifier - 6.0, 6.1.0, 7.0.1

Quantity recalled1309

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1082-2014
FDA event ID: 67223
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 25 Nov 2013
FDA classified: 6 Mar 2014
Reported: 12 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

25 Nov 2013	Recall initiated by company
6 Mar 2014	Classified by FDA	+101 days
12 Mar 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

Where it was distributed

Worldwide Distribution: US (nationwide): AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, including Puerto Rico, DC; and countries of: Albania, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia & Herzego, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore Slovakia, South Africa, South Korea, Spain, Sudan, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Idaho Illinois Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Stores named: Target

Questions about this recall

Is Desktop Pro TM linear accelerator control recalled?

Yes. Elekta recalled Desktop Pro TM linear accelerator control on 25 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-1082-2014.

Why was it recalled?

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Which lots are affected?

Identifier - 6.0, 6.1.0, 7.0.1

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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