Clarity Medical Systems Recalls RetCam 3 Halogen Lamps for Premature Failure
Clarity Medical Systems is recalling 234 RetCam 3 halogen lamps that may fail early, potentially damaging internal electrical components.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly limits the potential damage to internal electrical components and does not report any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Clarity Medical Systems, Inc. is recalling 234 halogen lamp components used in the RetCam 3 System. The affected lamps are from lot #020612C and are associated with RetCam 3 units with specific serial numbers listed in the recall notice.
The recall is being issued because the halogen lamps have the potential to fail sooner than their expected life. This premature failure could result in damage limited to the internal electrical components inside the RetCam 3 computer module. The RetCam 3 System is used for general ophthalmic imaging, including retinal, corneal, and external imaging, as well as photo-documentation of pediatric ocular diseases.
The affected products were distributed worldwide, including in the United States (nationwide to specific states) and in numerous international countries. Users of the RetCam 3 System should check their equipment serial numbers against the list provided by the manufacturer and contact Clarity Medical Systems for instructions on replacing the affected lamps.
The recalled product
- 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…
- Manufacturer
- Clarity Medical Systems Inc
- Affected units
- 234
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot of Halogan Lamp Component is #020612C. RetCam 3
Distribution
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