Terminated

Medical Linear Accelerator

FDA Recall Z-2721-2016 · Posted None

Recalling FirmElekta, Inc.

Recall StatusTerminated

Product CodeIYE

Date Initiated2016-07-08

Date Terminated2017-11-24

Product Quantity553

Reason for Recall

There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

Firm Action

Important Field Safety Notice 200-01-103-081 was released July 8, 2016 for distribution to all customers with Digital Accelerators without XVI. It informs users of the specific product and version numbers affected by the issue. The modification involves an inspection and correction procedure. Should the inspection pass, the corrected in not required. All gantry base wheel bolts should be checked for presence and torque and should be replaced if found to be showing signs of fatigue. Elekta service is actively reaching out to affected customers in order to organize a time to implement the inspection and correction. The notice included an acknowledgment form to be returned.

Root Cause

Other

Distribution Pattern

AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil, China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Japan, Jordan, Lebanon, Libya, Morocco, Mexico, Nigeria, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Portugal, Serbia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, Yemen

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051932ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5Elekta, Inc. · 2005-08-12

Official Source

View FDA Recall →

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