Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therap

FDA device recall Z-1492-2014 · posted 2014-04-24 · Terminated

Recall details

Recalling firm

Ion Beam Applications S.A.

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).

Action taken

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

Root cause

Software design

Status

Terminated

Product code

LHN

Quantity affected

4

Distribution

US Distribution including the states of OK, IL, NJ, and WA.

Date initiated

2013-12-04

Date posted

2014-04-24

Date terminated

2014-06-12

Location

Louvain La Neuve, Belgium

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