510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-2200-2011

Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian...

Varian Medical Systems, Inc. / initiated 2011-03-30 / Terminated / root cause: software
FDA source (opens on fda.gov)

Varian Medical Systems, Inc. Oncology Systems began a recall of Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian Medical Systems Inc., Palo Alto, CA. For use with... on . The reason FDA records is "A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2200-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Varian Medical Systems, Inc.
Product
Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian Medical Systems Inc., Palo Alto, CA. For use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
Product code
IYE Accelerator, Linear, Medical
Reason for recall
A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral offset error.
Root cause tag
software
FDA root cause
Software design
Action
On 3/30/2011, Varian distributed an Urgent Medical Device Correction Urgent Field Safety Notice to all affected users, with a description of the problem and identification of the affected product. The letter also informed customers of how they can determine if the problem affects them. The letter states that there is no work around for the issue unless they possess a FastPlan system. Varian is preparing a software patch to correct the issue and it will be applied to all OGP v2.6 and v2.6.1 systems. Customers are to advise the appropriate personnel of the content of the letter. If further clarification is needed, customers are to contact their local Varian Customer Support District or Regional Manager.
Quantity in commerce
598 units
Distribution
Worldwide Distribution
Product codes and lots
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 ,HZI0117 ,HZI0293 ,HZI0495 ,HZ10656 ,HZll0ll ,HZ12038 ,HZ12089 ,HZ13050 ,HZ17042 ,HZ18068 ,HZ19045  ,HZI0121 ,HZlO294 ,HZI0496 ,HZI0659 ,HZll013 ,HZ12039 ,HZ12090 ,HZ13052 ,HZ17043 ,HZ18069 ,HZ19046  ,HZI0126 ,HZI0295 ,HZ10497 ,HZI0663 ,HZll014 ,HZ12040 ,HZ12091 ,HZ13053 ,HZ17044 ,HZ18070 ,HZ19051  ,HZI0138 ,HZI0297 ,HZI0500 ,HZ10665 ,HZll015 ,HZ12041 ,HZ12092 ,HZ13054 ,HZ17046 ,HZ18076 ,HZ19052  ,HZI0144 ,HZ10299 ,HZ10501 ,HZ10670 ,HZll016 ,HZ12042 ,HZ12093 ,HZ13055 ,HZ17048 ,HZ18077 ,HZ19053  ,HZlO146 ,HZlO303 ,HZI0507 ,HZI0674 ,HZll017 ,HZ12043 ,HZ12094 ,HZ13056 ,HZ17049 ,HZ18079 ,HZ19055  ,HZlO148 ,HZI0305 ,HZI0508 ,HZI0675 ,HZll018 ,HZ12044 ,HZ12095 ,HZ13057 ,HZ17051 ,HZ18085 ,HZ19056  ,HZlO151 ,HZI0311 ,HZI0509 ,HZI0676 ,HZll019 ,HZ12045 ,HZ12096 ,HZ13058 ,HZ17057 ,HZ18088 ,HZ19059   ,HZ19060 ,HZ19086 ,HZl9109 ,HZ19129 ,HZ19158 ,HZ19193 ,HZ19926   ,HZ19062 ,HZ19087 ,HZ19113 ,HZ19130 ,HZ19159 ,HZ19194 ,HZ19996   ,HZ19065 ,HZ19088 ,HZ19114 ,HZ19131 ,HZ19162 ,HZ19195 ,HZ19997   ,HZ19066 ,HZ19089 ,HZ19115 ,HZ19133 ,HZ19167 ,HZ19201 ,HZ19998   ,HZl9068 ,HZ19091 ,HZl9117 ,HZ19134 ,HZ19170 ,HZ19226   ,HZ19069 ,HZ19095 ,HZ19118 ,HZ19135 ,HZ19171 ,HZ19227   ,HZ19071 ,HZ19096 ,HZ19119 ,HZ19140 ,HZ19172 ,HZ19228   ,HZ19072 ,HZ19098 ,HZ19121 ,HZ19141 ,HZ19179 ,HZ19229   ,HZ19076 ,HZ19099 ,HZ19125 ,HZ19142 ,HZ19186 ,HZ19235   ,HZ19078 ,HZ19104 ,HZ19126 ,HZ19143 ,HZl9189 ,HZ19236   ,HZ19079 ,HZ19106 ,HZ19128 ,HZ19155 ,HZ19190 , and HZ19611.