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U.S. Department of Health and Human Services

Class 2 Device Recall GammaPod Stereotactic Radiotherapy System

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 Class 2 Device Recall GammaPod Stereotactic Radiotherapy Systemsee related information
Date Initiated by FirmJuly 03, 2019
Create DateJuly 25, 2019
Recall Status1 Terminated 3 on July 01, 2021
Recall NumberZ-2081-2019
Recall Event ID 83342
510(K)NumberK180571 
Product Classification System, radiation therapy, radionuclide - Product Code IWB
ProductGammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device 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 Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005
FEI Number 3014273653
Recalling Firm/
Manufacturer		 Xcision Medical Systems, LLC
9176 Red Branch Rd
Ste O
Columbia MD 21045-2001
For Additional Information ContactDaniel Robert Plonski
443-681-7468
Manufacturer Reason
for Recall		One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm sent a Field Correction Notice letters dated 7/3/19 to customers. The letter identified the affected product, problem and actions to be taken. If you need any further information or support concerning this issue, please contact Xcsion Customer Support at 855-924-7466.
Quantity in Commerce2
DistributionThe products were distributed to the following US states: MD and TX.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IWB
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