—#138999

Product

Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K945278
Affected lot / code info: All TraumaDiagnost products that were delivered before the week of July 2, 2007.

Why it was recalled

If arm is not fastened securely it could fall down.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-07-22
Terminated: 2020-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138999. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.