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U.S. Department of Health and Human Services

Class 2 Device Recall Panoramic Corp. PC1000

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  Class 2 Device Recall Panoramic Corp. PC1000 see related information
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
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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