Recall Z-1087-2024 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
PHILIPS MEDICAL SYSTEMS
CombiDiagnost R90 1.0 (709030)
| Date | Feb 14, 2024 (initiated Feb 11, 2022) |
| Status | Open, Classified |
| Reason | While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size. |
| Root cause | Software design |
| Action | An Important Product Notice (2021-PD-DXR-034) dated February 15, 2022 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to follow the provided instructions to ensure there are no pending images before an exam circulate the notice to all users and to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions. |
| Quantity | 86 units |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163210 | Philips CombiDiagnost R90 Philips Medical Systems Dmc GmbH, Jan 31, 2017 |