Panoramic PC-1000 X-ray Systems Recalled for Safety Nut Defect
Panoramic Rental Corp. is voluntarily correcting PC-1000 X-ray systems because a safety nut may be ineffective, posing a risk of blunt force trauma to the head, neck, or shoulders.
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 blunt force trauma to the head, neck, or shoulders, which constitutes a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems. The recall involves the Panoramic X-ray Model PC-1000 and Laser-1000 packed in a crate, manufactured by Panoramic Rental Corp.
The correction is being performed due to the potential for a safety nut to be ineffective. This defect could result in blunt force trauma that may impact the head, neck, or shoulders of the user.
The affected units are distributed nationwide in the US, including Puerto Rico. The specific model numbers are 800724-1 and 800724-3, with serial numbers ranging from 6001 to 19340. A total of 13,340 units are involved in this correction.
The recalled product
- Product
- Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
- Manufacturer
- Panoramic Rental Corp.
- Hazard
- 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 (3)
- Model Number(s): 800724-1
- 800724-3
- Serial numbers 6001 to 19340
Distribution
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