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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-1843-2021
Recall Event ID 87814
510(K)Number K131473  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Quanta System Sterile Optical Laser Fiber, single use
Code Information Product Part Numbers:  OAF002011 - lots A194207, A194208, A194528, A194529, A201001, A201002  OAF005511 - lots A184635, A192114, A193613, A194527, A202027  OAF006001 - lots A183626 and A193106  OAF008001 - lot A193616  OAF009901 - lot A192911 and A193108  OAF009911 - lots A192914 and A202028  OAF302711 - lot A202029  OAF402011 - lots A380350, A384633, A392907  OAF702711 - lots A190301, A192113, A192906, A193110, A193111, A193112, A194108, A194211, A194532  OAF703611 - lots A180300, A190302, A190303, A192115, A192908, A193102, A193113, A194209, A194210, A195013, A195014 
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 2427 units
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, S.P.A.
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