Phoroptor VRx Digital Refraction System head may become loose or detach
Reichert, Inc. is recalling 122 units of the Phoroptor VRx Digital Refraction System Model 16241 due to an assembly defect that could cause the device head to become loose and potentially detach.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a structural assembly defect with risk of component detachment, qualifying as a risk-of-harm product. The source contains no reports of injuries or illnesses, keeping the score at 3 per the rubric.
Plain-English summary
Reichert, Inc. is recalling the Phoroptor VRx Digital Refraction System, Model 16241. The recall is due to an assembly defect that could cause the device head to become loose and potentially detach.
The recall affects 122 units distributed nationwide in the United States and internationally to Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and the United Kingdom.
The U.S. Food and Drug Administration is overseeing this Class II recall.
The recalled product
- Product
- Phoroptor VRx Digital Refraction System Model Numbers: 16241
- Manufacturer
- Reichert, Inc.
- Hazard
- loose-component
- detachment-risk
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 (3)
- Model Numbers: (1) 16241
- UDI-DI: (1) 00812559011716
- Serial Numbers: TBD
Distribution
Distributed nationwide across the United States.
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