The Recall Desk
HighFDA (Devices)·Z-1005-2017·Announced 2017-01-18

Philips Clinix RF Plus X-ray System Recalled for Tilt Hazard

Philips is recalling 41 Clinix RF Plus X-ray systems because liquid penetration can cause an unintentional tilt of the diagnostic table.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (unintentional table tilt) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 41 units of the FV-RF (Clinix RF Plus) stationary X-ray system. The recall is due to a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table.

This liquid penetration can cause a short circuit of the terminals of the tilt operation, which may result in an unintentional tilt of the table. The affected units were distributed nationwide in the following states: AL, CA, FL, GA, HI, IL, IN, KS, LA, MA, MI, MS, NJ, NY, OH, PA, SC, VA, WI, WV, and WY.

Healthcare facilities should check their system serial numbers against the list provided in the recall notice to determine if their equipment is affected. Affected serial numbers include 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, and 0162P21004.

The recalled product

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 accessori
Affected units
41

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically: