GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA.
FDA Recall Z-0487-2007 · Posted 2007-01-11
Recalling FirmVarian Medical Systems
Recall StatusTerminated
Product CodeJAQ
Date Initiated2006-09-11
Date Terminated2007-05-18
Product Quantity1 unit
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.