Z-0724-2018Class II

Integrity R1.2

Name: Z-0724-2018 Integrity R1.2
Creator: Elekta Limited
Published: 2017-11-20
License: https://open.fda.gov/license/

Elekta Limited / initiated 2017-11-20 / Terminated / root cause: software

FDA source

Elekta Limited began a recall of Integrity R1.2 on 2017-11-20. FDA classified it as Class II and gives the reason as "Potential for positional errors following automatic table movement (ATM)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0724-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-20
Posted: 2018-02-26
Terminated: 2024-03-15
Recalling firm: Elekta Limited
Product: Integrity R1.2
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potential for positional errors following automatic table movement (ATM).
Root cause tag: software
FDA root cause: Software Design Change
Action: Customers were notified via letter on about [DATE]. Instructions include to post the notice in a place accessible to all users until the action is closed and to advise appropriate personnel working with the affected product of the recall action. Additionally Elekta plans to release Integrity R4.0.0, which should identify positional errors over 5 mm, in the first half of 2018.
Quantity in commerce: 539 units total
Distribution: Distributed domestically to 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, WY. Distributed internationally to ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINIA, 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, ZIMBABWE
Product codes and lots: Product code 90I--YE, no serial number

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0724-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0723-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-26
Z-0724-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-26

Product code IYE

K112613Class IIIntegrity(tm)Elekta Limited / cleared 2011-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)