FDAClass IIJanuary 18, 2017

FV-RF (Clinix RF Plus) Product Usage: A Stationary recall

FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical…

Why was FV-RF (Clinix RF Plus) Product Usage: A Stationary recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical…
Recalling firm
Philips Medical Systems (Cleveland) Inc
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.
Recall date
January 18, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls