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U.S. Department of Health and Human Services

Class 2 Device Recall GammaPod Treatment Planning System

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 Class 2 Device Recall GammaPod Treatment Planning Systemsee related information
Date Initiated by FirmNovember 30, 2023
Date PostedJanuary 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0750-2024
Recall Event ID 93684
510(K)NumberK172706 K180571 
Product Classification System, radiation therapy, radionuclide - Product Code IWB
ProductGammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
Code Information 00850002615029(11)230321(21)TPS0018 (Distributed in the US) 00850002615029(11)230629(21)TPS0013 (Distributed in the US) 00850002615005(11)21H24(21)TPS0016 (Distributed in the US) 00850002615029(11)210629(21 )TPS0014 (Italy)
Recalling Firm/
Manufacturer		 Xcision Medical Systems, LLC
9176 Red Branch Rd Ste O
Columbia MD 21045-2001
For Additional Information ContactMichelle Crawley
443-681-7500
Manufacturer Reason
for Recall		Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
FDA Determined
Cause 2		Software design
ActionXcision issued Urgent Field Correction Letter via email on 11/30/23. Letter states reason for recall, health risk and action to take: Please post this notification internally for awareness of GammaPod BY CUSTOMER/USER Treatment Planning System users. Xcision is working on an update to the TPS software to implement controls to identify not only the patient identification but also the series of which the structures were delineated. This change is expected for implementation in early 2024. If you need any further information or support concerning this issue, please contact Xcision Customer Support at 855-924-7466 (1-855- SUPPORT XCISION).
Quantity in Commerce4 units
DistributionWorldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.
Total Product Life CycleTPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IWB
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