Phoroptor VRx Digital Refraction System (Reichert) – Head Detachment Risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Brand
Reichert, Inc.
Lot Codes / Batch Numbers
Model Numbers: (1) 16241, UDI-DI: (1) 00812559011716, Serial Numbers: TBD
Products Sold
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.
Reichert, Inc. is recalling Phoroptor VRx Digital Refraction System Model Numbers: 16241 due to The head of the phoropter head could come loose and potentially detach due to a default in the assembly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026