| Date Initiated by Firm | March 21, 2017 |
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| Create Date | April 17, 2017 |
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| Recall Status1 |
Terminated 3 on September 19, 2018 |
| Recall Number | Z-1830-2017 |
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| Recall Event ID |
76804 |
| 510(K)Number | K152224 |
|---|
| Product Classification |
radiation therapy system - Product Code LHN
|
| Product | Proteus 235, Proton Therapy System |
|---|
| Code Information |
Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0 |
Recalling Firm/
Manufacturer |
Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
|
Manufacturer Reason
for Recall | In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data. |
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FDA Determined
Cause 2 | Software design |
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| Action | A Field Safety Notice was mailed to the customer affected by the issue on 03/21/2017. The Notice informed the user when resuming from a partial irradiation, to ensure that the correct delivered dose has been selected in the partial report dialog box before proceeding with irradiation. |
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| Quantity in Commerce | 2 worldwide, 1 in U.S. |
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| Distribution | Distribution in US (to Louisiana), and France. |
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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.
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| 510(K) Database | 510(K)s with Product Code = LHN
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