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U.S. Department of Health and Human Services

Class 2 Device Recall QUANTUM Surgical EPIONE

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 Class 2 Device Recall QUANTUM Surgical EPIONEsee related information
Date Initiated by FirmAugust 05, 2024
Date PostedOctober 09, 2024
Recall Status1 Completed
Recall NumberZ-0037-2025
Recall Event ID 95194
510(K)NumberK223758 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductThe EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
Code Information UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
Recalling Firm/
Manufacturer		 QUANTUM SURGICAL SAS
1000 rue du mas de verchant
ZAC Eureka
montpellier France
Manufacturer Reason
for Recall		Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
FDA Determined
Cause 2		Under Investigation by firm
ActionQuantum Surgical issued an URGENT FIELD SAFETY NOTICE to its sole consignee via visit on 08/05/2024 and followed up with an email on 08/19/2024. The notice explained the problem, potential risk, and requested that the consignee cease use of the device. The affected units were returned, repaired, and replaced.
Quantity in Commerce2 units
DistributionUS Nationwide distribution in the state of FL.
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.
510(K) Database510(K)s with Product Code = JAK
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