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U.S. Department of Health and Human Services

Class 2 Device Recall GreenLight HPS Fiber Optics, Model Number 102090

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  Class 2 Device Recall GreenLight HPS Fiber Optics, Model Number 102090 see related information
Date Initiated by Firm January 22, 2010
Date Posted September 25, 2010
Recall Status1 Terminated 3 on January 25, 2011
Recall Number Z-2502-2010
Recall Event ID 56418
510(K)Number K062719  
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079
Code Information Manufactured between August 21 and October 31, 2009-- Lot number/Affected units: 932: D, N, U, Z; 933: A, C, F, H, K, L, M, T; 934: B, D, N, U, V, W, Y, Z; 935: A, C, F, H, K, L, M, T; 936: B, D, N, U, V, W, Y, Z; 937: A, C, F, H, K, L, M, T; 938: B, D, N, U, V, W, Y, Z; 939: A, B,L, M, T, V, W, Y; 940: B, D, N, U, V, W, Y, Z.
Recalling Firm/
Manufacturer		 AMS Innovative Center - San Jose
3070 Orchard Dr
San Jose CA 95134-2011
For Additional Information Contact
408-943-0636 Ext. 6703
Manufacturer Reason
for Recall		 Product may be packed with incorrect external or internal labels and/or missing product insert.
FDA Determined
Cause 2		 Labeling mix-ups
Action Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010.
Quantity in Commerce 11668 units
Distribution Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia.
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 = LASERSCOPE
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