Recalls / —

—#181038

Product

Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.

FDA product code

KPR — System, X-Ray, Stationary

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K945278

Affected lot / code info

All serial numbers

Why it was recalled

If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Philips North America, LLC

Address

3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2020-04-07

Terminated

2023-04-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #181038. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.