Device product
FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Z-1005-2017
Product summary
- Event
- Event 75994
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41
- Official record key
device-enforcement:Z-1005-2017
Official wording
Reason: There's a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause an unintentional tilt of the table.
Code information: System Serial Numbers: 0162R15403 0162A66105 0162A65401 218134 217530 209677 716334 217721 0162R16001 0162A65301 0162R15803 0162R16002 209669 0162R15504 0162R15602 0162A66104 0162R16007 0162R15802 0162R15702 0162R16003 212866 218047 0162A66005 0162R15603 0162R16004 218085 0162R15804 217296 0162A65402 0162P21004
Distribution pattern: US Nationwide distribution in the following states: AL, CA, FL, GA, HI, IL, IN, KS, LA, MA, MI, MS, NJ, NY, OH, PA, SC, VA, WI, WV, & WY.
Derived failure modes
-
Unknown
There's a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause an unintentional tilt of the table.