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U.S. Department of Health and Human Services

Class 2 Device Recall Quanta System

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  Class 2 Device Recall Quanta System see related information
Date Initiated by Firm April 27, 2021
Create Date June 10, 2021
Recall Status1 Terminated 3 on September 05, 2023
Recall Number Z-1844-2021
Recall Event ID 87814
510(K)Number K160513  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Quanta System Sterile Optical Laser Fiber, reusable
Code Information Product Part Numbers:  OAF002013 Lots A201003  OAF005513 Lots A184636, A192118, A193101  OAF006003 Lot A195008  OAF008003 Lots A193615, A194021  OAF008013 Lots A183623, A192119  OAF009903 Lots A193109, A193617  OAF009913 Lots A181350, A192910  OAF702713 Lots A182415, A193104, A194109, A194723  OAF703613 Lot A180150            
Recalling Firm/
Manufacturer		 Quanta System, S.p.A.
Via Acquedotto 109
Samarate Italy
For Additional Information Contact Stephen Lieberman
561-302-0777
Manufacturer Reason
for Recall		 Product sterility is potentially compromised.
FDA Determined
Cause 2		 Process control
Action The recalling firm is sending recall notification letters to its consignees for further dissemination to the user level. Consignees are asked to cease use of impacted product, quarantine impacted goods and dispose of goods in accordance with local regulations. Consignees should complete and return the acknowledgement form.
Quantity in Commerce 307
Distribution Nationwide distribution via 6 US distributors
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GEX and Original Applicant = QUANTA SYSTEM SPA
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