FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1005-2017
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Status
- Terminated
- Initiated
- 2016-11-18
- Posted
- not on file
- Terminated
- 2018-07-02
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K984111"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28