—#148189

Product

Philips DuraDiagnost stationary X-ray system

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141381
Affected lot / code info: SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093

Why it was recalled

Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Philips plans to bring the products into compliance with the Federal standard at no cost to customers by implementing a field correction. 1. You will contact customers and initiate the actions to correct the failure to comply issues. 2. You will attach the warning label to maintain an audible volume, and issue a supplement to the user manual that instructs the user how to adjust the volume for the local noise environment and include a warning that the user shall maintain an audible volume. 3. You will attach the identification label to the affected Height-Adjustable Tabletop. 4. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. If you need any further information or support concerning this, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.

Timeline

Recall initiated: 2015-09-17
Posted by FDA: 2016-09-01
Terminated: 2017-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148189. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.