Recall Z-1492-2014— Ion Beam Applications S.A.
Class II · Terminated
Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2013-12-04, terminated 2014-06-12. It names one FDA 510(k) clearance: K082416. Product: Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy. Reason: Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0)..
- Recalling firm
- Ion Beam Applications S.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-04
- Terminated
- 2014-06-12
- Firm location
- Louvain La Neuve, N/A, Belgium
510(k) clearances named in this recall
1 on FDA's recordK-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 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.