Z-1005-2017Class II

FV-RF (Clinix RF Plus)

Name: Z-1005-2017 FV-RF (Clinix RF Plus)
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-11-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-11-18 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions... on 2016-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1005-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-18
Posted: 2017-01-11
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
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.
Product code: KPR System, X-Ray, Stationary
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1005-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1005-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code KPR

K984111Class IIFv-RFPhilips Medical Systems (Cleveland), Inc. / cleared 1998-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)