CLASS II Device recall · Reported 21 Aug 2019 · FDA Enforcement Report

iGUIDE System recalled by Elekta

Elekta is recalling iGUIDE System, distributed nationwide in the US. The recall was initiated on 19 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersion 2.2.0, Product Code/GTIN Number: 04056719001704; Version 2.2.1, Product Code/GTIN Number: 04056719001742; Version 2.2.2, Product Code/GTIN Number: 04056719002039

Quantity recalled374 devices

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-2230-2019
FDA event ID: 83180
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 19 Jun 2019
FDA classified: 9 Aug 2019
Reported: 21 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

19 Jun 2019	Recall initiated by company
9 Aug 2019	Classified by FDA	+51 days
21 Aug 2019	Published in enforcement report	+12 days

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

Reason for recall

Potential for iGUIDE to incorrectly monitor the 3D position.

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

iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

Where it was distributed

Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.

Nationwide Alaska Alabama California Colorado Connecticut Florida Georgia Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina North Dakota

Questions about this recall

Is iGUIDE System recalled?

Yes. Elekta recalled iGUIDE System on 19 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-2230-2019.

Why was it recalled?

Potential for iGUIDE to incorrectly monitor the 3D position.

Which lots are affected?

Version 2.2.0, Product Code/GTIN Number: 04056719001704; Version 2.2.1, Product Code/GTIN Number: 04056719001742; Version 2.2.2, Product Code/GTIN Number: 04056719002039

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.

More recalls from Elekta

All 122

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Fletcher CT/MR Shielded Applicator Set Intracavitary Remote recalled	Elekta	Other	Nationwide
17 Jun 2026Device	CLASS II	Mosaiq Oncology Information System recalled by Elekta	Elekta	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Leksell Vantage Arc System recalled by Elekta	Elekta	Device Malfunction	28 states

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide