Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx

FDA device recall Z-2195-2011 · posted 2011-05-13 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail.

Action taken

The firm, Varian Medical, sent an "Urgent Medical Device Correction" Letter dated March 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect all hard wedges for missing or sheared screw fasteners, if any wedge is found to have one or more missing or sheared screw fasteners, remove the wedge from use and notify Varian immediately; inspect all hard wedges for loose screw fasteners, and retighten as necessary, and implement a program of monthly inspection of wedges for loose or missing hardware. The customers were also instructed to advise the appropriate personnel working in their Radiotherapy Department of the content of this letter. Varian Service shall immediately begin an interim action to replace screw fasteners on all hard wedges for Clinacs installed prior to January 2004. Varian Service will contact the customers to arrange for the inspection visit. Varian also stated that they shall continue their Investigation of this issue to further clarify the exact conditions under which the wedge screw fasteners may fail, and to analyze possible final solutions. Varian will notify the customers when final determinations are made. If you require further clarification, please feel free to contact your local Varian Customer Support Services Manager and/or USA and Canada at 1-888-4265; Europe: +41 41 749 8844; or email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.Helpdesk@varian.com; Japan: Japan.apps helpdesk@varian.com; Latin America: soporte.al@varian.com, a d Internet: Oncology Systems-www.myvarian.com or Varian Medical Systems - www.varian.com.

Root cause

Process control

Status

Terminated

Product code

IYE

Quantity affected

5616 units

Distribution

Worldwide distribution:

Date initiated

2011-03-28

Date posted

2011-05-13

Date terminated

2013-06-07

Location

Palo Alto, CA

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