Date Initiated by Firm |
August 19, 2016 |
Create Date |
October 04, 2016 |
Recall Status1 |
Terminated 3 on January 11, 2018 |
Recall Number |
Z-0016-2017 |
Recall Event ID |
75017 |
510(K)Number |
K870236 K882436
|
Product Classification |
Unit, x-ray, extraoral with timer - Product Code EHD
|
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.
|
Code Information |
Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340 |
Recalling Firm/ Manufacturer |
Panoramic Rental Corp. 4321 Goshen Rd Fort Wayne IN 46818-1201
|
For Additional Information Contact |
Panoramic Corporation 800-654-2027
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
Device Design |
Action |
Panoramic Corporation sent an Urgent Medical Device Correction letter dated August 19, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached form and return to Panoramic. For questions contact Panoramic at correction@pancorp.com or 888-381-2577 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST in order to verify the effectiveness of the safety component. |
Quantity in Commerce |
13,340 |
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.
|
510(K) Database |
510(K)s with Product Code = EHD and Original Applicant = PANORAMIC CORP.
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