Midmark Vantage Panoramic X-Ray System Recalled for Collimator Failure
Midmark Corp dba Progeny Inc is recalling 832 Vantage Panoramic X-Ray Systems because a primary collimator failure may cause unintentional movement without an error message.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (unintentional movement of an X-ray device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
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
- 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.
Lot numbers (20)
- Model Number: 60-A0001
- ZA05002
- ZA05003
- ZA05004
- ZA05005
- ZA05006
- ZA05007
- ZA05008
- ZA05009
- ZA05010
- ZA05011
- ZA05012
- ZA05013
- ZA05014
- ZA05015
- ZA05016
- ZA05017
- ZA05018
- ZA05019
- ZA05020
Distribution
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