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 Versio
Check against the official notice below — it lists the full affected range.
Philips North America is recalling certain Allura and Azurion X-ray imaging systems due to a software defect in the Philips StentBoost Live R2.0 feature. The defect may cause the system to display X-ray images that were processed during a previous procedure instead of the current one. This means a physician could potentially view an image from a different patient or an earlier scan of the same patient rather than the current X-ray image being performed.
A total of 338 units have been distributed globally and throughout the United States. The recall affects Allura models 722010, 722012, 722026, 722027, 722028, 722029, and 722035, as well as Azurion models 722063, 722064, 722067, 722068, 722078, and 722079. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Global Distribution. US Nationwide. Quantity: 338 Lot/code info: UDI: (01)00884838059030(21)839 (01)00884838085275(21)131 (01)00884838059054(21)577 (01)00884838085350(21)81 (01)00884838085367(21)271 (01)00884838054202(21)879 (01)00884838054202(21)1783 (01)00884838054202(21)1447 (01)00884838099241(21)282 (01)00884838099258(21)512 (01)00884838099258(21)360 (01)00884838099258(21)370 (01)00884838099258(21)584 (01)00884838099272(21)239 (01)00884838099258(21)425 (01)00884838099258(21)232 (01)00884838099258(21)591 (01)00884838099258(21)580 (01)00884838099258(21)39 (01)00884838099241(21)198 (01)00884838099258(21)589 (01)00884838099258(21)362 (01)00884838085268(21)954 (01)00884838099234(21)10 (01)00884838099241(21)214 (01)00884838099272(21)183 (01)00884838099258(21)526 (01)00884838099258(21)441 (01)00884838099272(21)121 (01)00884838099258(21)80 (01)00884838099258(21)326 (01)00884838099258(21)518 (01)00884838099258(21)404 (01)00884838099241(21)252 (01)00884838099258(21)453 (01)00884838099258(21)472 (01)00884838099258(21)465 (01)00884838099272(21)129 (01)00884838099272(21)174 (01)00884838099258(21)553 (01)00884838099258(21)517 (01)00884838099258(21)400 (01)00884838099258(21)342 (01)00884838099258(21)582 (01)00884838099241(21)196 (01)00884838085268(21)1391 (01)00884838099258(21)485 (01)00884838099258(21)262 (01)00884838099258(21)277 (01)00884838099272(21)120 (01)00884838085268(21)703826 (01)00884838085367(21)38 (01)00884838085367(21)36 (01)00884838085275(21)139 (01)00884838085268(21)1199 (01)00884838085251(21)940 (01)00884838085251(21)945 (01)00884838
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.