Class 2 Device Recall TraumaDiagnost

• Date Initiated by Firm: July 22, 2015
• Create Date: February 05, 2016
• Recall Status: Terminated on October 14, 2020
• Recall Number: Z-0766-2016
• Recall Event ID: 71764
• 510(K)Number: K945278
• Product Classification: System, x-ray, stationary - Product Code KPR
• Product: Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
• Code Information: All TraumaDiagnost products that were delivered before the week of July 2, 2007.
• Recalling Firm/ Manufacturer: Philips Electronics North America Corporation; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: 978-659-3000
• Manufacturer Reason for Recall: If arm is not fastened securely it could fall down.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPR