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. | Device Design |
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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. |
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13,340 |
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US Nationwide Distribution including Puerto Rico |
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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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