Recall Z-1501-2025— Reichert, Inc.
Class II · Ongoing
Class II FDA medical device recall by Reichert, Inc., initiated 2025-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Phoroptor VRx Digital Refraction System Model Numbers: 16242. Reason: The head of the phoropter head could come loose and potentially detach due to a default in the assembly..
- Recalling firm
- Reichert, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-28
- Firm location
- Depew, NY, United States
Product description
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Reason for recall
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.