Varian Medical Systems Class Il

Company: Varian Medical Systems
Date of Enforcement Report:8/23/2006
Class:ll

PRODUCT
a) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst
and vers.-row, part number GM11005400, for the GammaMed model 12i
radionuclide applicator system, Recall # Z-1398-06;
b) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst
and vers.-row , part number GM11005400, for the GammaMed model 12it
radionuclide applicator system, Recall # Z-1399-06

REASON
Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.

CODE
a) GammaMed ”12i” serial numbers: GM00797 GM00795 GM00896 GM00852
GM00873 GM00708 GM0F278 GM00710 GM00848 GM00899 GM00820
GM00757 GM00821 GM00889 GM00727 GM00706 GM0710 GM00898
GM00743 GM00826 GM00784 GM00786;
b) GammaMed ”12it” serial numbers: GM00213 GM00218 GM00219TB GM00215
GM00202 GM00216 GM00217 GM00212 GM00219TA GM00219 GM00210
GM00214 GM0213

RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, CharlottesvilleVA, by letter on 4/17/06 and continuing through 5/1/06.
Manufacturer: Varian Medical Systems, Haan, Germany. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
35 units

DISTRIBUTION
Nationwide

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.