Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0016-2017 — 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.

U.S. FDA — Device Enforcement · United States · 2016-08-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0016-2017
Date of alert: 2016-08-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Panoramic Rental Corp.
Product category: device
Product type: Devices

Reported risk: Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0016-2017 — 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.

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