Midmark Vantage Panoramic X-Ray System Recalled for Firmware Error
Midmark Corp dba Progeny Inc is recalling 58 Vantage Panoramic X-Ray systems due to a firmware error that may cause the unit's column to continue moving vertically after the control button is released.
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 mechanical failure in a medical device that could result in injury, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Midmark Corp dba Progeny Inc is recalling 58 units of the Vantage Panoramic X-Ray System. The recall involves firmware versions 3.0, 3.1, 3.2, and 3.3 used in the Real Time Controller (RTC) of the device. The affected units were distributed nationwide in the United States, including Puerto Rico, as well as in Australia, Canada, and Russia.
The recall was initiated because an error in the firmware may cause the vertical column of the X-Ray unit to continue moving even after the movement control button is released. This failure to stop the column's movement presents a potential safety risk to patients and operators.
Healthcare facilities and consumers who possess these specific serial numbers should stop using the affected units and contact Midmark Corp dba Progeny Inc for further instructions on the recall process.
The recalled product
- Product
- The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and…
- Manufacturer
- Midmark Corp dba Progeny Inc
- Category
- Medical Device — Dental Imaging
- Affected units
- 58
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)
- Vantage Panoramic X-Ray System firmware versions: 3.0
- 3.1
- 3.2
- Serial Numbers ZM81025
- ZM81026
- ZM81030
- ZZ08005
- ZZ08006
- ZZ08007
- ZZ08008
- ZZ08009
- ZZ08010
- ZZ08011
- ZZ08012
- ZZ08013
- ZZ08015
- ZZ08016
- ZZ08017
- Z08018
- ZZ08019
Distribution
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