The Recall Desk
HighFDA (Devices)·Z-0016-2017·Announced 2016-10-12

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.

What this means for you

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.
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Panoramic Rental Corp.

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