Class 2 Device Recall Halogen Lamp component in RetCam 3 System

• Date Initiated by Firm: March 07, 2014
• Date Posted: March 20, 2014
• Recall Status: Terminated on August 11, 2014
• Recall Number: Z-1265-2014
• Recall Event ID: 67702
• 510(K)Number: K081858
• Product Classification: Camera, ophthalmic, ac-powered - Product Code HKI
• Product: Halogen Lamp component in RetCam 3 System - ; ; Clarity Medical Systems, Inc;; Pleasanton, CA.; ; General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
• Code Information: Lot of Halogan Lamp Component is #020612C. RetCam 3, Part number 21-100500. RetCam 3 affected serial numbers: RC3066 RC3079 RC6013 RC6033 RC6034 RC6035 RC6036 RC6037 RC6038 RC6039 RC6040 RC6041 RC6043 RC6044 RC6045 RC6047 RC6049 RC6050 RC6053 RC6054 RC6055 RC6056 RC6057 RC6058 RC6059 RC6060 RC6063 RC6064 RC6066 RC6067 RC6068 RC6069 RC6070 RC6071 RC6072 RC6073 RC6074 RC6075 RC6076 RC6077 RC6078 RC6079 RC6080 RC6081 RC6082 RC6083 RC6084 RC6085 RC6086 RC6087 RC6088 RC6089 RC6090 RC6092 RC6093 RC6094 RC6095 RC6096 RC6098 RC6099 RC6101 RC6102 RC6103 RC6104 RC6105 RC6106 RC6107 RC6108 RC6109 RC6110 RC6111 RC6112 RC6113 RC6301 RC6302 RC6303 RC6304 RC6305 RC6306 RC6307 RC6309 RC6310 RC6311 RC6312 RC6313 RC6314 RC6315 RC6316 RC6317 RC6318 RC6319 RC6320 RC6321 RC6322 RC6323 RC6324 RC6325 RC6326 RC6327 RC6328 RC6329 RC6330 RC6331 RC6332 RC6333 RC6334 RC6335 RC6336 RC6337 RC6338 RC6339 RC6340 RC6341 RC6342 RC6343 RC6344 RC6364
• Recalling Firm/ Manufacturer: Clarity Medical Systems Inc; 5775 W Las Positas Blvd Suite 200; Pleasanton CA 94588-4084
• For Additional Information Contact: Gary Seeger; 925-463-7984 Ext. 218
• Manufacturer Reason for Recall: One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, Clarity, sent a "Field Bulletin" dated March 12, 2014 to customers - risk managers and distributors by e-mail on March 12, 2014. They plan to follow this with a second letter on or about March 28, 2014 which will include a second bulletin, replacement bulbs and installation instructions. Clarity stated in the letter to its customers "In the meantime, you may continue to use your RetCAM 3." If you have any question of concerns, please contact Clarity at +1 925 621 322 or email to: service@retcam.com
• Quantity in Commerce: 234 lamps
• Distribution: Worldwide Distribution: US (nationwide) to states of: TN, MA, CA, TX, MD,FL, MS, IL, and PA; and to countries of: France, Thailand, Egypt, Mexico, Kuwait, India, Austria,Japan, Sweden, Peru, United Kingdom, Philippines,The Netherlands, China,, UAE,Israel, Germany, Italy.
• 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 = HKI and Original Applicant = CLARITY MEDICAL SYSTEMS