Midmark Vantage Panoramic X-Ray System Recalled for Collimator Failure

Plain-English summary

Midmark Corp dba Progeny Inc is recalling 832 Vantage Panoramic X-Ray Systems. These Class II extra-oral X-ray systems are used for dental and orthodontic radiological imaging, including the diagnosis of diseases of the teeth, jaw, and oral structures. The systems are distributed worldwide, including in the United States and various international markets.

The recall is due to a potential failure of the primary collimator, which may result in the unintentional movement of the device. The source text notes that this unintentional movement will not generate an error message. No specific injuries, illnesses, or deaths are reported in the provided source text.

Healthcare providers and consumers should contact Midmark Corp dba Progeny Inc for instructions on how to address the defect. The recall number is Z-0651-2016.

The recalled product

Product

Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures.

Manufacturer

Midmark Corp dba Progeny Inc

Category

Medical Device — Dental Imaging

Hazard

• unintentional-movement

Affected units

832

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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