FDA Medical Device Recalls (openFDA)
Reichert, Inc.: Phoroptor VRx Digital Refraction System Model Numbers: 16241
- Recall number
- Z-1500-2025
- Recalling firm
- Reichert, Inc.
- Product
- Phoroptor VRx Digital Refraction System Model Numbers: 16241
- Status
- Open, Classified
- Initiated
- 2025-02-28
- Posted
- 2025-03-31
- Terminated
- not on file
- Reason
- The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 122 units
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HKN
- Firm FEI
- 1000159913
- Firm city
- Depew
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28