Z-0766-2016Class II

Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for...

Name: Z-0766-2016 Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for...
Creator: Philips Electronics North America Corporation
Published: 2015-07-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-07-22 / Terminated / root cause: manufacturing process

FDA source

Philips Electronics North America Corporation began a recall of Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis on 2015-07-22. FDA classified it as Class II and gives the reason as "If arm is not fastened securely it could fall down". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0766-2016
Classification: Class II
Status: Terminated
Initiated: 2015-07-22
Posted: 2016-02-05
Terminated: 2020-10-14
Recalling firm: Philips North America LLC
Product: Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
Product code: KPR System, X-Ray, Stationary
Reason for recall: If arm is not fastened securely it could fall down.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified of the recall via letter sent certified return receipt on 7/22/2015. The letter informs customers that the Instruction for Use (IFU) requires the operator not to use the system and call for service, if a mechanical defect or malfunction is suspected. In this case, it is recommended not to position the Ceiling suspension with the Trauma arm directly above a patient as long as this Field Change Order is not yet installed. Philips plans to repair the affected systems. A Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. For questions, contact your local representative or use the Technical Support Line at 1-800-722-9377. When communicating with Philips regarding this issue, please reference Field Change Order 72000014.
Quantity in commerce: 399 distributed, 262 are subject to this event
Distribution: Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland.
Product codes and lots: All TraumaDiagnost products that were delivered before the week of July 2, 2007.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0766-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0766-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)