FDA Medical Device Recalls (openFDA)
Philips North America, LLC: Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
- Recall number
- Z-1806-2020
- Recalling firm
- Philips North America, LLC
- Product
- Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
- Status
- Terminated
- Initiated
- 2020-04-07
- Posted
- not on file
- Terminated
- 2023-04-28
- Reason
- If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
- Root cause
- Device Design
- Action
- Philips issued Urgent Field Safety Notice (FCO72000015) sent 4/09/20 via certified mail states reason for recall health risk, action to take: The IfU (Instruction for Use) require the operator to not use the system and call for service, if a mechanical defect or malfunction is suspected. As soon as a deformation is determined, the system may no longer be used and call the service engineer. Should you feel uncertain regarding these instructions, please contact Philips. If you would like any further information or support concerning this issue, please contact your local Philips representative.
- Quantity
- 346 units (5 US and 341 OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of CA, ME, RI, TX, WI and the countries of Canada, Australia, Austria, France, Germany, Greece, Hungary, Ireland, Netherlands, Portugal, Slovenia, United Kingdom.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K945278"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- 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