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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus 325

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 Class 2 Recall
Proteus 325
see related information
Date Posted April 24, 2014
Recall Status1 Terminated on June 12, 2014
Recall Number Z-1492-2014
Recall Event ID 67678
Premarket Notification
510(K) Number
K082416 
Product Classification System, Radiation Therapy, Charged-Particle, Medical - Product Code LHN
Product Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Code Information Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.
Recalling Firm/
Manufacturer
Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve
Manufacturer Reason
for Recall
Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action Ion Beam Applications ( IBA) sent a recall notification letter dated on/about December 5, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Short term action: A user notice (see annex 1) has been sent to impacted sites where the affected legacy PTS software version was delivered. This user notice explains the workaround required to be put in place in order to fully mitigate the risk and the 1BA action plan to permanently fix this issue. Corrective action: A patch on the PTS Legacy SW was requested and in implementation. In the same time, the solution was put in main code of PTS legacy software version 7 to be integrated in the next release. The customer representative signing underneath confirms that the user notice above is communicated to the appropriate employees. We apologize in advance for any inconvenience this may cause and we would like to thank you for your cooperation. The IBA Site Staff or the Operations manager is available to provide you with additional information and/or guidelines if necessary. Further questions please call : 215-972-7777.
Quantity in Commerce 4
Distribution US Distribution including the states of OK, IL, NJ, and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LHN and Original Applicant = ION BEAM APPLICATIONS S.A.
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