Z-1806-2020Class II

Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 -

Name: Z-1806-2020 Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 -
Creator: Philips North America, LLC
Published: 2020-04-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-04-07 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography on 2020-04-07. FDA classified it as Class II and gives the reason as "If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury". 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-1806-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-07
Posted: 2020-04-28
Terminated: 2023-04-28
Recalling firm: Philips North America LLC
Product: Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Product code: KPR System, X-Ray, Stationary
Reason for recall: If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1806-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1806-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-28

Product code KPR

K945278Class IIPhilips Bucky Diagnost FamilyPhilips Medical Systems North America, Inc. / cleared 1994-12-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)