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U.S. Department of Health and Human Services

Class 2 Device Recall Panoramic Xray Model PC1000

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  Class 2 Device Recall Panoramic Xray Model PC1000 see related information
Date Initiated by Firm June 04, 2015
Date Posting Updated September 01, 2015
Recall Status1 Terminated 3 on May 30, 2017
Recall Number Z-2538-2015
Recall Event ID 71653
510(K)Number K882436  K870236  
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
Product Panoramic X-ray Model PC-1000

The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Code Information Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003
Recalling Firm/
Manufacturer
Panoramic Rental Corp.
4321 Goshen Rd
Fort Wayne IN 46818-1201
For Additional Information Contact Steve Yaggy
800-654-2027
Manufacturer Reason
for Recall
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
FDA Determined
Cause 2
Equipment maintenance
Action The firm, Panoramic Corporation, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 7/17/2015 via certified mail to customers on 7/20/2015, with response forms for customers to complete and return. The firm previously issued "IMPORTANT SERVICE BULLETIN" notices in 2003 and 2008 via FED-EX. The letter describes the product, problem and actions to be taken. The customers are instructed to select to use several options including replacing the failing part with one containing the safety feature, or trading in their machine for a newer one; discontinue using the devices immediately regardless the option you select, and complete and return the attached response card via email to recall@pancorp.com or fax to 260-489-5683. If the machine has been sold or donated to another dental outfit, the customer should notify Panoramic so that they can update their records. When the customer is reached, the firm will confirm whether or not the machine is still in service. Customers with questions may contact 800-654-2027 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST to discuss these options and determine which is best for their practice.
Quantity in Commerce 7885
Distribution Worldwide distribution: US (nationwide) all 50 states, including Puerto Rico; and countries of Antigua, Armenia, Aruba, Austria, Canada, China, Colombia, Ecuador, Egypt, England, France, Germany, Greece, Haiti, Honduras, Indonesia, Japan, Kenya, Lithuania, Mexico, Panama, Saudi Arabia, Singapore, Taiwan, Turkey, UAE, Uganda, Venezuela, Vietnam, and Virgin Islands.
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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