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U.S. Department of Health and Human Services

Class 2 Device Recall Integre Pro (Yellow LP561, LP6RY, Scan Green LP6G, Green LP5532), Spare Optics Bench V2

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  Class 2 Device Recall Integre Pro (Yellow LP561, LP6RY, Scan Green LP6G, Green LP5532), Spare Optics Bench V2 see related information
Date Initiated by Firm March 16, 2023
Date Posted June 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-1971-2023
Recall Event ID 92532
510(K)Number K142398  K081565  
Product Classification Laser, ophthalmic - Product Code HQF
Product Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532
Spare, Optics Bench V2, L2G/LP6G
Code Information Serial Nos., UDI IPY0374, (01) 0 9342395 00012 0 ISRY0242, (01) 0 9342395 00015 1 ISG0370, (01) 0 9342395 00024 3 IPG0539, (01) 0 9342395 00009 0 BG1190
Recalling Firm/
Manufacturer		 Ellex Medical Pty Ltd.
3-4 Second Ave
Mawson Lakes Australia
For Additional Information Contact Richard Knapczyk
952-767-5781
Manufacturer Reason
for Recall		 When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Ellex Safety Bulletin is the customer notification letter. Ellex will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For questions contact your local Ellex-Lumibird representative or email us on eservice@ellex.com.
Quantity in Commerce 57 systems in total (6 units shipped to United States)
Distribution US nationwide/ Worldwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HQF and Original Applicant = Ellex Medical Pty. Ltd.
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