🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: March 7, 2014 Clarity Medical Systems Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Clarity Medical Systems Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1265-2014

Related Recalls