Recall Z-2682-2016 ยท KPR System, X-Ray, Stationary
Philips Electronics North America Corporation
Philips DuraDiagnost stationary X-ray system
| Date | Sep 1, 2016 (initiated Sep 17, 2015) |
| Status | Terminated |
| Reason | 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 | Radiation Control for Health and Safety Act |
| Action | 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 c |
| Quantity | 15 |
| Distribution | US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141381 | DURADIAGNOST Philips Healthcare (Suzhou) Co., Ltd., Jun 12, 2014 |