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Terminated

Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.

FDA Recall Z-1195-2007 · Posted 2007-08-29

Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-04-18
Date Terminated2010-08-12
Product Quantity291 units

Reason for Recall

Patient positioning errors may occur because of mechanical variations during product installation.

Firm Action

The firm issued a notification letter to all customers April 18, 2007. The firm intends to arrange for service personnel to contact affected sites to verify the calibration of the OBI system, and make arrangements to correct any issues. The firm will also update installation manuals to clearly describe the OBI installation and calibration requirements.

Root Cause

Device Design

Distribution Pattern

Worldwide, including USA, Puerto Rico, Australia, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Italy, Japan, Luxembourg, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Netherlands, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042720ON-BOARD IMAGER DEVICEVarian Medical Systems · 2004-10-29K041519MODIFICATION TO: ON-BOARD IMAGER DEVICEVarian Medical Systems, Inc. · 2004-08-04K040192ON-BOARD IMAGER DEVICEVarian Medical Systems, Inc. · 2004-02-27

Official Source

View FDA Recall →

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

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