GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Inten
Summary
The FDA issued a Class II for GammaPod - Treatment Planning System-a component of the GammaPod Irradiation Sys by Xcision Medical Systems, LLC. Reason: Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected.
Details
Source
Device Recall
External ID
Z-0750-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
GammaPod - 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.
Lot/Code Info: 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)
Quantity Affected: 4 units
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
Distribution
Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-30
Company
Columbia, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Xcision Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Xcision Medical Systems, LLC have FDA actions?
This is the only FDA action we have on record for Xcision Medical Systems, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0750-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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