Z-1501-2025Class II

Phoroptor VRx Digital Refraction System Model Numbers: 16242

Name: Z-1501-2025 Phoroptor VRx Digital Refraction System Model Numbers: 16242
Creator: Reichert, Inc.
Published: 2025-02-28
License: https://open.fda.gov/license/

Reichert, Inc. / initiated 2025-02-28 / Open, Classified / root cause: manufacturing process

FDA source

Reichert, Inc. began a recall of Phoroptor VRx Digital Refraction System Model Numbers: 16242 on 2025-02-28. FDA classified it as Class II and gives the reason as "The head of the phoropter head could come loose and potentially detach due to a default in the assembly". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1501-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-28
Posted: 2025-03-31
Recalling firm: Reichert, Inc.
Product: Phoroptor VRx Digital Refraction System Model Numbers: 16242
Product code: HKN Refractor, Manual, Non-Powered, Including Phoropter
Reason for recall: The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Root cause tag: manufacturing process
FDA 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 in commerce: 1876 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.
Product codes and lots: Model Numbers: 16242; UDI-DI: 00812559011730; 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1501-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1500-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-31
Z-1501-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-31

Product code HKN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)