Reported Mar 26, 2014 · Terminated
Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging…
Clarity Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clarity Medical Systems Inc · 5775 W Las Positas Blvd Suite 200 · Pleasanton, CA · 94588-4084
Is this the product you have?
- 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.
- Lot codes and dates
- Lot of Halogan Lamp Component is #020612C. RetCam 3, Part number 21-100500
- RetCam 3 affected serial numbers
117 of 117 codes
RC3066RC3079RC6013RC6033RC6034RC6035RC6036RC6037RC6038RC6039RC6040RC6041RC6043RC6044RC6045RC6047RC6049RC6050RC6053RC6054RC6055RC6056RC6057RC6058RC6059RC6060RC6063RC6064RC6066RC6067RC6068RC6069RC6070RC6071RC6072RC6073RC6074RC6075RC6076RC6077RC6078RC6079RC6080RC6081RC6082RC6083RC6084RC6085RC6086RC6087RC6088RC6089RC6090RC6092RC6093RC6094RC6095RC6096RC6098RC6099
- Amount recalled
- 234 lamps
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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