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Phoroptor VRx Digital Refraction System recallZ-1500-2025 · Reichert, Inc. · initiated Feb 28, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Reichert, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

On February 28, 2025 "URGENT MEDICAL DEVICE RECALL" letters were sent to customers. PLEASE TAKE THE FOLLOWING ACTIONS IMMEDIATELY. 1. Inspect your Phoroptor head with reference to Figure 1 for looseness or rocking and Figure 2 for an excessive gap between components. Figure 3 shows the normal condition. 2. If your unit exhibits looseness or rocking or if there is an excessive gap between components, it is possible that your unit has the defect condition. Please remove it from service immediately and contact Reichert Technical Support at 1-888-849-8955 or at https://www.reichert.com/en/support/rma-request so that the unit can be inspected and, if necessary, repaired by Reichert. The repair will be completed at no cost to you. 3. If your unit shows the normal condition as in Figure 3, please install the Support Bracket when you receive it. It is essential that you install the Support Bracket for the safety of patients and operators even if the components appear tight and securely connected. Without the bracket, there could be eventual separation of the components. The Support Bracket prevents this possibility. The internal investigation into this issue has indicated the need for these corrections and resulted in a plan that includes actions designed to prevent a recurrence of this situation. Reichert prides itself on the quality of devices we manufacture. Please share this letter with all the relevant personnel in your organization. Please contact Reichert Technical Support with any questions. They can be reached Monday through Friday, 8:00AM to 5:00PM Eastern Time at 1-888-849-8955 or at https://www.reichert.com/en/support/support-and-service-inquiry.

Recall details

Recall number
Z-1500-2025
Status
Open, Classified
Initiated by the company
Feb 28, 2025
Posted by the FDA
Mar 31, 2025
Recalling firm
Reichert, Inc.
Quantity
122 units
Product code
HKN
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.

Product description

Phoroptor VRx Digital Refraction System Model Numbers: 16241

Code information (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96266).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page