Recall Z-2154-2017 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Electronics North America Corporation
Philips DigitalDiagnost 3.1.x X-Ray System
| Date | May 11, 2017 |
| Status | Terminated |
| Reason | 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 | Software design |
| Action | 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 b |
| Quantity | US - 132 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST Philips Medical Systems Dmc GmbH, Jul 25, 2014 |