Recall Z-1477-2018— Ion Beam Applications S.A.

Name: FDA recall Z-1477-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-26

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2018-01-26, terminated 2020-04-27. It names one FDA 510(k) clearance: K101508. Product: Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.. Reason: When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2018-01-26
Terminated: 2020-04-27
Firm location: Louvain La Neuve, N/A, Belgium

510(k) clearances named in this recall

1 on FDA's record

K101508 — MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235Ion Beam Applications S.A.·cleared 2010-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Reason for recall

When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.

Data sourced from openFDA. This site is unofficial and independent of the FDA.