FDA Medical Device Recalls (openFDA)
Ion Beam Applications S.A.: ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
- Recall number
- Z-0747-2022
- Recalling firm
- Ion Beam Applications S.A.
- Product
- ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
- Status
- Open, Classified
- Initiated
- 2022-02-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
- Root cause
- Device Design
- Action
- IBA issued Urgent Medical Device Correction notification on February 15, 2022 directly to customer either by hand or by email. Letter states reason for recall, health risk and action to take: For Proton Therapy sites where the system is operated by the customer: - Warn operators to not manually change the beam range (action called manual set range ) while a patient is on the Patient Positioning System. - IBA will provide a training to all operators about the correct use of the action called manual set range and the risk associated to its use while a patient is on the Patient Positioning System. This training will be provided on your site by August 31, 2022. Contact: Vigilance@iba-group.com. Help Desk: +32 2 507 20 81 (available 24/7)
- Quantity
- 15 units US; 22 units OUS
- Distribution
- IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,
- Lot, serial or model codes
- PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (EU), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.109 (UK), SBF.110 (UK), SBF.112 (EU), SBF.113 (US), SBF.115 (UK), SBF.117 (EU), SBF.128 (US). UDI: (01)05404013801138
- 510(k) numbers
- ["K163500"]
- PMA numbers
- not on file
- Product code
- LHN
- Firm FEI
- 3000256071
- Firm city
- Louvain-la-neuve
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28