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U.S. Department of Health and Human Services

Class 2 Device Recall Gendex eXpert DC Intraoral Dental XRay System

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  Class 2 Device Recall Gendex eXpert DC Intraoral Dental XRay System see related information
Date Initiated by Firm December 29, 2011
Date Posted April 02, 2012
Recall Status1 Terminated 3 on June 01, 2012
Recall Number Z-1358-2012
Recall Event ID 61295
510(K)Number K992610  
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
Product Gendex eXpert DC Intraoral Dental X-Ray System

Device is to be used as an extra-oral source of X-Rays in Dental Radiography
Code Information Model # EXPERTDC75NA, serial numbers 2007017, 2006983, 2007018, 2006982, 2003916, 2007015, 2007051, 2007021, 2006975, 2003900, 2006987, 2007027, 2006989, 2003812, 2007024, 2006985, 2006986, 2006980, 2007025, 2007026, 2006979, 2006976, 2003840, 2003906, 2003820, 2006977, 2007023, 2006978, 2003917, 2003907, 2003904, 2007028, 2007022, 2007019, 2003829, 2003876, 2003909, 2003920, 2003862, 2007029, 2007016, 2003937, 2003877, 2007020, 2003835, 2003908; model # EXPERTDC55NA, serial numbers 2004394, 2004396, 2004437, 2004430, 2004436, 2004416
Recalling Firm/
Manufacturer		 Gendex Dental Systems
1910 N Penn Rd
Hatfield PA 19440-1959
For Additional Information Contact Elizabeth Lazaro
215-954-0365
Manufacturer Reason
for Recall		 Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Gendex Dental Systems sent a Urgent Medical Device Correction letter dated December 29, 2011, to both affected customers. The Customers were provided background information and details on how the nonconforming installations of the devices would be corrected. Gendex Dental Systems apologizes for any inconvenience caused by this issue, and request your corporation as we correct this problem. The customers were instructed to complete and return the Acknowledgement Form upon receipt of the recall notification letter and fax to (215) 997-5665. For further questions please call (215) 954-0365.
Quantity in Commerce 52
Distribution USA including the states of Iowa and Illinois.
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 = DENTSPLY INTL.
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