Terminated

Agility with Integrity R3.2

FDA Recall Z-0723-2018 · Posted None

Recalling FirmElekta Limited

Recall StatusTerminated

Product CodeIYE

Date Initiated2017-11-20

Date Terminated2024-03-15

Product Quantity539 units total

Reason for Recall

Potential for positional errors following automatic table movement (ATM).

Firm 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.

Root Cause

Software Design Change

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123808AGILITYElekta , Ltd. · 2013-04-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.