Proteus 235

FDA device recall Z-2592-2017 · posted 2017-06-19 · Terminated

Recall details

Recalling firm

Ion Beam Applications S.A.

Reason for recall

It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.

Action taken

Ion Beam Application S.A. (IBA) will bring the defect into compliance: 1. Providing recommendations for user actions which, if followed, will prevent dark current. In order to prevent the error from occurring, the IBA customers are provided with a specific QA map that would detect dark current and instructions on how and when to use it (Annex 1). This guidance was included in IBAs User Notice which was sent to users on February 9, 2017. 2. IBA is developing a long term solution consisting of a new IC-cyclo (ionization chamber located at the cyclotron exit) and a Beam Absence Electronic Unit (BAEU) along with a software upgrade. This solution will detect presence of dark current between irradiations. It will prevent starting a new irradiation if dark current is present. This solution is currently in test phase and will be completed in two years. 3. Manufacturer will provide the FDA with progress reports on the effectiveness of the plan, including the number of electronic products repaired on a quarterly basis. The first progress report will be provided to the FDA by September 15, 2017 to the correspondence identified below. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2.Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions please call (571) 449-4992.

Root cause

Device Design

Status

Terminated

Product code

LHN

Quantity affected

18 systems ( 10 in the US)

Distribution

Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.

Date initiated

2017-02-09

Date posted

2017-06-19

Date terminated

2023-07-14

Location

Louvain La Neuve, Belgium

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