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Terminated

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

FDA Recall Z-1806-2020 · Posted None

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2020-04-07
Date Terminated2023-04-28
Product Quantity346 units (5 US and 341 OUS)

Reason for Recall

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

Firm 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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945278PHILIPS BUCKY DIAGNOST FAMILYPhilips Medical Systems North America, Inc. · 1994-12-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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