Phoroptor VRx Digital Refraction System head detachment hazard recall
Reichert's Phoroptor VRx Digital Refraction System head may detach from its mounting bracket and fall onto patients or operators. The recall affects 87 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm medical device with potential for fall injury to patients or operators. The source contains no reports of injuries, and the hazard is characterized as potential rather than confirmed, meeting the High (Score 3) criteria rather than higher severity tiers.
Plain-English summary
Reichert, Inc. is recalling the Phoroptor VRx Digital Refraction System, Model 16242, because the optical head may detach from the mounting bracket that connects it to an ophthalmic stand. When detachment occurs, the head can fall onto a patient or device operator, creating a risk of injury.
A total of 87 units are affected by this recall—53 units were initially identified, and 34 additional units were identified in an extended recall on July 3, 2024. All affected units were distributed nationwide. Affected equipment is identified by serial number as listed in the recall notice.
Healthcare facilities and eye care professionals should cease use of affected units and contact Reichert, Inc. for further instructions.
The recalled product
- Product
- PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation
- Manufacturer
- Reichert, Inc.
- Hazard
- detachment
- fall-hazard
- impact-injury
Distribution
Distributed nationwide across the United States.
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