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Terminated

GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA

FDA Recall Z-0486-2007 · Posted 2007-01-11

Recalling FirmVarian Medical Systems
Recall StatusTerminated
Product CodeJAQ
Date Initiated2006-09-11
Date Terminated2007-05-18
Product Quantity31 total units

Reason for Recall

Medical device for patient treatment does not meet electrical safety standards.

Firm Action

The recalling firm notified end users by e-mail and letter on 09/11/06 and advised that some devices did not comply with electrical safety standards. The firm stated that they plan to make modifications to improve electrical safety performance but users may continue to use the device to treat patients. The notification included a response form for users to fax back verification of receipt.

Root Cause

Other

Distribution Pattern

Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912555GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADERRts Technology, Inc. · 1991-08-02K891131GAMMAMED 12IMick Radio-Nuclear Instruments, Inc. · 1989-08-07

Official Source

View FDA Recall →

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

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