Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other

FDA device recall Z-2434-2021 · posted 2021-09-08 · Open, Classified

Recall details

Recalling firm

Ion Beam Applications S.A.

Reason for recall

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

Action taken

IBA issued an Urgent Medical Device Correction notification users of the device, starting June 14, 2021. Letter states reason for recall, health risk and action to take: IBA would like to remind Proteus235 users to verify with X-ray images or other means, after the display of the popup message, that the patient positions (represented by the couch position, mainly the 3 translations and 3 rotations parameters) recorded in the OIS are correct Labelling change IBA will update the user manuals to: - Describe under which conditions the popup message appears and the subsequent risks, especially that the equipment positions may not be up to date in the OIS, - Remind the user to verify with X-ray images or other means, after the display of the popup message, that the patient positions (represented by the couch position, mainly the 3 translations and 3 rotations parameters) recorded in the OIS are correct, - Recommend the user to verify the OIS user manuals for measures preventing saving outdated patient positions in case of disconnection and to apply these measures before saving the positions in the OIS. The action will be completed for your site by May 31, 2022. By signing below, the customer representative confirms that this notice has been read, understood and communicated to the appropriate employees within the organization. Please transfer this notice to other organizations on which this action has an impact. Your IBA representative is able to provide you with additional information and/or guidelines if necessary. Please return the copy of the notice signed to IBA within 10 working days .

Root cause

Device Design

Status

Open, Classified

Product code

LHN

Quantity affected

27 worldwide, 11 in U.S.

Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.

Date initiated

2021-06-14

Date posted

2021-09-08

Location

Louvain-la-neuve, Belgium

Related 510(k) clearances