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Terminated

Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and Ximatron treatment systems. Model numbers H14, H18, H27, H72, H77. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

FDA Recall Z-0117-2009 · Posted 2008-10-20

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-08-11
Date Terminated2010-11-27
Product Quantity3296 units

Reason for Recall

During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers.

Firm Action

Recall initiated on 08/11/2008. Notification will be sent to Varian Sales, Marketing and Service organizations as well as to all affected users. Contact Varian Medical Systems Oncology Systems, at 1-650-424-5731 for assistance.

Root Cause

Device Design

Distribution Pattern

Worldwide including to the US and to Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, The Netherlands, United Kingdom, Algeria, Australia, Bahrain, Bangladesh, Belorussia, Bolivia, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guadeloupe, Hong Kong, India, Indonesia, Iran, Israel, Jamaica, Japan, Kazakhstan, Lebanon, Macau, Macedonia, Malaysia, Martinique, Mexico, Morocco, Nepal, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Russian Fed., Saudi Arabia, Serbia, Montenegro, Singapore, South Africa, South Korea, Sudan, Syria, Taiwan, R.O.C., Thailand, Turkey, U.A.E, Ukraine, Uruguay, Venezuela, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033339ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHYVarian Medical Systems, Inc. · 2003-12-30K904364VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500CVarian Assoc., Inc. · 1991-02-27

Official Source

View FDA Recall →

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

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