—#155677

Product

Philips DigitalDiagnost 3.1.x X-Ray System

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141736
Affected lot / code info: DigitalDiagnost Upgrade Release 3.1.x to 3.1.3

Why it was recalled

During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.

Root cause (FDA determination)

Software design

Action the firm took

Philip's planned action to bring defect into compliance: 1. You will contact customers and initiate a software update to correct the issue that incorrectly notifies the user of the detectors being ready. 2. You will install the software/firmware and perform testing to ensure the software update was effective. 3.You will provide a customer notification letter that includes a statement that you will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2.Philips Healthcare will implement this CAP by November 10, 2017. If you need any further information or support concerning this Issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377. We apologize for any inconvenience this may cause and trust that this information is adequately addressing any concerns you may have.

Recalling firm

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

Distribution

Distribution pattern: USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI

Timeline

Recall initiated: 2017-05-11
Terminated: 2018-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155677. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.