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PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 &… recallZ-0517-2018 · Panoramic Rental Corp. · initiated Jul 14, 2017

Class II Terminated All recalls posted in January 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Panoramic Rental Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.

FDA root cause category: Device Design

What the company is doing

On July 14, 2017, Panoramic distributed Urgent Medical Device Correction notices to customers who own and have not taken action as required for the PC-1000 X-ray system machines. This means that your device does not have a critical safety feature that is intended to protect your patients and staff from harm. Customers are encouraged to immediately discontinue use of their machine and follow the instructions in the notice. Customers are encouraged to not resume use of the machine until a certified Panoramic service technician repairs the lift motor. Customers are advised to contact Panoramic to ensure any safety risks associated with the lift motor are identified and addressed. Action Required: (A) If your PC1000 machine is still in service at this location, you must immediately discontinue use and choose one of the following by returning the Acknowledgement Form or contacting the Panoramic Service Team by calling 888-381-2577 Monday through Friday 8 am - 6 pm. 1. An upgraded lift motor assembly at no cost to you; 2. A digital Panoramic rental unit to replace your PC1000, contingent on a signed one year rental contract (subject to availability); or 3. A new digital Panoramic or PanoramicCephalometric unit to replace your PC1000 at a reduced price (starting at $17,995 depending on machine type and subject to availability) (B) If your PC1000 machine is no longer in service or under your control: 4. If the machine is no longer in service, Panoramic will provide free removal of your machine.

Recall details

Recall number
Z-0517-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 14, 2017
Posted by the FDA
Jan 9, 2018
Recalling firm
Panoramic Rental Corp.
Quantity
13,340 units
Product code
EHD
FDA submissions
K870236, K882436
Distribution
US Nationwide distribution including Puerto Rico

Product description

PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3

Code information (models, lots, serial numbers)

Serial Numbers: 6001 to 19340

Other devices under the same FDA submission

2 devices cleared under K870236, K882436 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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