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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 Recall
GreenLight HPS Fiber Optics, Model Number 102090
see related information
Date Posted September 25, 2010
Recall Status1 Terminated on January 25, 2011
Recall Number Z-2502-2010
Recall Event ID 56418
Premarket Notification
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, California 95134-2011
Consumer Instructions Contact the recalling firm for information Contact the recalling firm for information
Manufacturer Reason
for Recall
Product may be packed with incorrect external or internal labels and/or missing product insert.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = LASERSCOPE
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