Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Fixed eye Safety filters

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Fixed eye Safety filterssee related information
Date Initiated by FirmFebruary 01, 2016
Create DateApril 07, 2016
Recall Status1 Terminated 3 on October 27, 2016
Recall NumberZ-1270-2016
Recall Event ID 73468
510(K)NumberK052777 
Product Classification Laser, ophthalmic - Product Code HQF
ProductEllex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
Code Information Model Number : 3143270
FEI Number 3002806902
Recalling Firm/
Manufacturer		 Laserex Systems Inc.
7138 SHADY OAK RD
EDEN PRAIRIE MN 55344-3517
For Additional Information Contact
800-824-7444
Manufacturer Reason
for Recall		The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
FDA Determined
Cause 2		Device Design
ActionEllex Medical Pty Ltd. Planned Action to bring into Compliance: 1.Field Corrective Action replacing all affected safety filters of all units manufactured between July 2012 and February 2016, 2.All repairs will be made at no cost to the purchaser; and 3.The corrections will be completed by March 30, 2017. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (800) 824-7444.
Quantity in Commerce72 units plus 2 spare units
DistributionWorldwide Distribution - US Distribution
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HQF
-
-