Summary
The FDA issued a Class II for Phoroptor VRx Digital Refraction System Model Numbers: 16241 by Reichert, Inc.. Reason: The head of the phoropter head could come loose and potentially detach due to a default in the assembly..
Details
Source
Device Recall
External ID
Z-1500-2025
Action Date
2025-04-09
Status
Ongoing
Category
device
Product Description
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Lot/Code Info: Model Numbers: (1) 16241; UDI-DI: (1) 00812559011716; Serial Numbers: TBD; Note: The majority of units within the scope of the planned recall are older devices which do not have a UDI on the label.
Quantity Affected: 122 units
Reason for Recall
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-28
Company
Depew, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 182 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Reichert, Inc. has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Reichert, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Reichert, Inc. have FDA actions?
Reichert, Inc. has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1500-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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