Class II Varian Medical Systems

Company: AGFA Corp.,
Date of Enforcement Report:8/23/2006
Class:lI

PRODUCT
Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators, Recall # Z-1375-06.

REASON
A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators.

CODE
H462074, H462000, H462003, H462004, H462005, H462006, H462011, H462012, H462013, H462014, H462015, H462016, H462017, H462018, H462019, H462020, H462021, H462022, H462023, H462024, H462025, H462026, H462027, H462028, H462029, H462031, H462040, H462045, H462047, H462048, H462049, H462050, H462051, H462052, H462054, H462055, H462057, H462059, H462060, H462061, H462064, H462065, H462066, H462067, H462068, H462072, H462073, H462075, H462076, H462077, H462079, H462082, H462083, H462084, H462085, H462086, H462087

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on September 20, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
58 units

DISTRIBUTION
Nationwide and Internationally

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Corporate Office

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