Devices

Device Recall Gendex eXpert DC Intraoral Dental XRay System

Model / Serial
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
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
USA including the states of Iowa and Illinois.
Product 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
Manufacturer
Gendex Dental Systems
1 Event
- Recall of Device Recall Gendex eXpert DC Intraoral Dental XRay System

Manufacturer

Gendex Dental Systems

Manufacturer Address
Gendex Dental Systems, 1910 N Penn Rd, Hatfield PA 19440-1959
Source
USFDA

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