Panoramic PC-1000 Dental X-ray Units Recalled for Lift Motor Wear
Panoramic Rental Corp. is recalling PC-1000 dental X-ray units because the lift motor may wear if not properly maintained, posing a risk of injury.
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 is classified as FDA Class II. The hazard involves a mechanical component (lift motor) that could fail due to maintenance issues, posing a risk of physical injury to patients or operators, but no specific injuries or fatalities are reported in the source text.
Plain-English summary
Panoramic Rental Corp. is recalling PC-1000 and PC-1000/Laser1000 dental X-ray units, model numbers 800724-2 and 800724-3. The recall involves 13,340 units with serial numbers ranging from 6001 to 19340. These units were distributed nationwide in the United States, including Puerto Rico.
The recall is being conducted because the lift motor used to raise and lower the overhead chassis may wear if it is not properly maintained according to the manufacturer's maintenance schedule. This wear could potentially lead to a malfunction of the lifting mechanism.
Healthcare facilities and users of these devices should contact Panoramic Rental Corp. for instructions on how to address the maintenance issue or obtain a repair. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
- Manufacturer
- Panoramic Rental Corp.
- Category
- Medical Device — Dental Imaging
- Affected units
- 13,340
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 (1)
- Serial Numbers: 6001 to 19340
Distribution
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