Reported Sep 6, 2023 · Ongoing
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive…
Reichert, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Reichert, Inc. · 3362 Walden Ave · Depew, NY · 14043-2437
Is this the product you have?
- PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye
- MODEL NUMBER16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest strabismus]
- Lot codes and dates
- GTIN0812559011730
- S/N
78824-122178825-122178826-122178827-122178828-122178829-122178830-122178831-122178832-122178833-122178834-122178835-122178836-122178837-122178838-122178839-122178840-122178841-122178842-122178843-122178844-122178845-122178846-122178847-122178848-122178849-122178850-122178851-122178852-122178853-012278854-012278855-012278856-012278857-012278858-012278859-012278860-012278861-012278862-012278863-012278864-012278865-012278866-012278867-012278868-012278870-012278871-012278872-012278873-012278874-0122
- S/N Extended Recall 7/3/24Serial Number
78875-022278876-022278877-022278878-022278879-022278880-022278881-022278882-022278883-022278884-022278885-022278886-022278887-022278888-022278889-022278890-022278891-022278892-022278893-022278894-022278895-022278896-022278897-022278898-022278899-022278900-022278901-022278902-022278903-022278904-022278905-022278906-022278907-022278908-022278909-0322
- Amount recalled
- 53 units; Extended 34 units
Where it was sold
- Nationwide
Why it was recalled
Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator
This product could cause temporary or reversible health problems — stop using it.
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