Recall Z-0874-2022 ยท LLZ System, Image Processing, Radiological
Philips North America Llc
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0
| Date | Feb 2, 2022 |
| Status | Open, Classified |
| Reason | Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction notification letters dated 2/2/22 were distributed to customers. 1. What is the problem and under what circumstances it can occur Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient. When the problem occurs, the area of the boosted images remains black, and the small X-ray viewer in the upper right corner will show a single static image of the previous run. The correct patien |
| Quantity | 338 |
| Distribution | Global Distribution. US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV, Aug 19, 2014 |
| K170144 | StentBoost Live Philips Medical Stystems Nederland BV, Jun 7, 2017 |
| K172822 | Azurion series R1.2 Philips Medical Systems Nederland B.V., Nov 22, 2017 |
| K181830 | Azurion R2.0 Philips Medical Systems Nederland B.V., Aug 2, 2018 |