| Date Initiated by Firm | April 10, 2017 |
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| Date Posted | May 03, 2017 |
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| Recall Status1 |
Terminated 3 on February 16, 2018 |
| Recall Number | Z-2097-2017 |
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| Recall Event ID |
76977 |
| 510(K)Number | K152224 |
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| Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
|
| Product | Proton therapy system -Proteus 235 aka Proteus Plus.
A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. |
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| Code Information |
Serial numbers: PAT.003, PAT.006 |
Recalling Firm/
Manufacturer |
Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
|
Manufacturer Reason
for Recall | A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose. |
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FDA Determined
Cause 2 | Software design |
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| Action | Target date for software update June 30, 2017.
A Field Safety Notice was issued on 4/10/2017 describing the problem and reminding users to follow guidance in the user's manual. |
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| Quantity in Commerce | 2 |
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| Distribution | FL |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = LHN
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