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Class 2 Device Recall Panoramic Xray Model PC1000, Laser1000 |
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Date Initiated by Firm |
July 14, 2017 |
Date Posted |
January 09, 2018 |
Recall Status1 |
Terminated 3 on July 23, 2018 |
Recall Number |
Z-0517-2018 |
Recall Event ID |
78105 |
510(K)Number |
K870236 K882436
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Product Classification |
Unit, x-ray, extraoral with timer - Product Code EHD
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Product |
PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 |
Code Information |
Serial Numbers: 6001 to 19340 |
Recalling Firm/ Manufacturer |
Panoramic Rental Corp. 4321 Goshen Rd Fort Wayne IN 46818-1201
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Manufacturer Reason for Recall |
The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.
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FDA Determined Cause 2 |
Device Design |
Action |
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. |
Quantity in Commerce |
13,340 units |
Distribution |
US Nationwide distribution including Puerto Rico |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = EHD and Original Applicant = PANORAMIC CORP.
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