Medical device recalls Moderate risk

Reichert, Inc. recalls Phoroptor VRx Digital Refraction System Model Numbers: 16241

Recall date
February 28, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1500-2025
FDA classification
Class II
Brand / firm
Reichert, Inc.
Sold / distributed
Domestic: Nationwide Distribution. International: 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 United Kingdom.

Why it was recalled

The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Phoroptor VRx Digital Refraction System Model Numbers: 16241

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