Recall Z-1005-2017 ยท KPR System, X-Ray, Stationary
Philips Medical Systems (Cleveland) Inc
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.
| Date | Nov 18, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated December 2, 2016 to customers via USPS certified letter with returned receipt. The letter identified the affected product, problem and actions to be taken. Additionally, your local Philips representative has been provided details regarding this Device Correction and can be contacted if you need any further information or support concerning this issue: Technical Support Line: 1-800-722-9377 |
| Quantity | 41 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984111 | FV-RF Philips Medical Systems (Cleveland), Inc., Dec 11, 1998 |