Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography
Recall
- Recall Number
- Z-1358-2012
- Event Number
- 61295
- Firm
- Gendex Dental Systems
- FEI Number
- 3009212242
- Product Code
- EHD
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 29, 2011
- Posted
- April 2, 2012
- Terminated
- June 1, 2012
- Address
- 1910 N Penn Rd, Hatfield, PA, 19440-1959
Description
Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography
Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.
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.
USA including the states of Iowa and Illinois.
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