Recall Z-1500-2025 ยท HKN Refractor, Manual, Non-Powered, Including Phoropter
Reichert, Inc.
Phoroptor VRx Digital Refraction System Model Numbers: 16241
| Date | Mar 31, 2025 (initiated Feb 28, 2025) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.