Philips North America Llc Recall 89787
Description: 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
Philips North America Llc Recall 89787 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0874-2022 |
| Event ID | 89787 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Global Distribution. US Nationwide. |
| Quantity | 338 |
| Recall 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. |
| Device Classification | 20220413 |
| Device 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)00884838085251(21)947 (01)00884838085268(21)703680 (01)00884838085251(21)964 (01)00884838085268(21)703724 (01)00884838085268(21)703541 (01)00884838085268(21)703815 (01)00884838085251(21)991 (01)00884838085251(21)1013 (01)00884838085251(21)943 (01)00884838085251(21)1025 (01)00884838085282(21)417 (01)00884838054202(21)511 (01)00884838085268(21)559 (01)00884838085268(21)560 (01)00884838085268(21)340 (01)00884838085350(21)45 (01)00884838085268(21)703560 (01)00884838054202(21)810 (01)00884838085350(21)272 (01)00884838085350(21)256 (01)00884838054189(21)364 (01)00884838054189(21)164 (01)00884838054189(21)1250 (01)00884838059030(21)226 (01)00884838059030(21)860 (01)00884838054189(21)1105 (01)00884838085251(21)464 (01)00884838085268(21)703523 (01)00884838085268(21)703524 (01)00884838085268(21)1418 (01)00884838085268(21)1209 (01)00884838085268(21)1427 (01)00884838085268(21)703537 (01)00884838085268(21)703538 (01)00884838085268(21)703517 (01)00884838085268(21)1426 (01)00884838054202(21)305 (01)00884838054196(21)139 (01)00884838085251(21)1003 (01)00884838085251(21)207 (01)00884838085251(21)209 (01)00884838085251(21)211 (01)00884838085251(21)447 (01)00884838085268(21)232 (01)00884838054189(21)412 (01)00884838054202(21)1547 (01)00884838054219(21)59 (01)00884838054240(21)92 (01)00884838085251(21)1005 (01)00884838085251(21)220 (01)00884838085251(21)799 (01)00884838099258(21)221 (01)00884838099227(21)62 (01)00884838099241(21)201 (01)00884838099241(21)185 (01)00884838099258(21)145 (01)00884838099258(21)257 (01)00884838099258(21)352 (01)00884838099258(21)353 (01)00884838099272(21)141 (01)00884838099258(21)368 (01)00884838099241(21)132 (01)00884838099241(21)165 (01)00884838099241(21)117 (01)00884838099241(21)195 (01)00884838099258(21)555 (01)00884838099241(21)267 (01)00884838099241(21)268 (01)00884838099241(21)271 (01)00884838099241(21)270 (01)00884838099241(21)255 (01)00884838099241(21)224 (01)00884838099227(21)56 (01)00884838099241(21)287 (01)00884838099241(21)114 (01)00884838099258(21)67 (01)00884838099241(21)239 (01)00884838099241(21)249 (01)00884838099241(21)141 (01)00884838099258(21)783 (01)00884838099258(21)531 (01)00884838099227(21)28 (01)00884838099241(21)142 (01)00884838099241(21)235 (01)00884838099241(21)227 (01)00884838085268(21)703959 (01)00884838099258(21)600 (01)00884838099241(21)348 (01)00884838099241(21)176 (01)00884838099258(21)634 (01)00884838099241(21)321 (01)00884838099241(21)123 (01)00884838099227(21)32 (01)00884838099227(21)72 (01)00884838099203(21)8 (01)00884838099227(21)64 (01)00884838099234(21)46 (01)00884838099241(21)91 (01)00884838099227(21)2 (01)00884838099265(21)4 (01)00884838099241(21)95 (01)00884838099241(21)283 (01)00884838099234(21)21 (01)00884838099234(21)22 (01)00884838099241(21)295 (01)00884838099272(21)140 (01)00884838099227(21)5 (01)00884838099227(21)6 (01)00884838099227(21)7 (01)00884838099227(21)74 (01)00884838099241(21)218 (01)00884838099265(21)38 (01)00884838099227(21)40 (01)00884838099227(21)15 (01)00884838099272(21)166 (01)00884838099227(21)47 (01)00884838099227(21)48 (01)00884838099227(21)13 (01)00884838099241(21)140 (01)00884838099241(21)9 (01)00884838099241(21)49 (01)00884838099241(21)20 (01)00884838099241(21)157 (01)00884838099258(21)597 (01)00884838099258(21)810 (01)00884838099272(21)171 (01)00884838099258(21)413 (01)00884838099241(21)76 (01)00884838085268(21)304 (01)00884838099203(21)48 (01)00884838099210(21)27 (01)00884838099258(21)270 (01)00884838099227(21)52 (01)00884838099258(21)416 (01)00884838099203(21)45 (01)00884838099241(21)291 (01)00884838099258(21)535 (01)00884838099272(21)86 (01)00884838099258(21)576 (01)00884838099258(21)345 (01)00884838099258(21)198 (01)00884838099258(21)126 (01)00884838099258(21)457 (01)00884838099258(21)117 (01)00884838099258(21)241 (01)00884838099258(21)510 (01)00884838099241(21)86 (01)00884838099265(21)60 (01)00884838099265(21)76 (01)00884838099258(21)168 (01)00884838099272(21)157 (01)00884838099258(21)137 (01)00884838085268(21)893 (01)00884838099258(21)473 (01)00884838099265(21)77 (01)00884838099265(21)20 (01)00884838099258(21)397 (01)00884838099272(21)73 (01)00884838099241(21)107 (01)00884838099258(21)392 (01)00884838099234(21)30 (01)00884838099272(21)137 (01)00884838099203(21)11 (01)00884838099265(21)67 (01)00884838099272(21)210 (01)00884838099265(21)64 (01)00884838099272(21)77 (01)00884838099258(21)142 (01)00884838099265(21)80 (01)00884838099241(21)166 (01)00884838099265(21)70 (01)00884838099272(21)28 (01)00884838099265(21)75 (01)00884838099272(21)192 (01)00884838099272(21)193 (01)00884838099234(21)27 (01)00884838099265(21)57 (01)00884838099258(21)692 (01)00884838099272(21)110 (01)00884838099265(21)34 (01)00884838099272(21)91 (01)00884838099241(21)200 (01)00884838099272(21)43 (01)00884838099272(21)161 (01)00884838099265(21)69 (01)00884838099265(21)61 (01)00884838099265(21)63 (01)00884838099258(21)157 (01)00884838099241(21)184 (01)00884838099265(21)13 (01)00884838099272(21)46 (01)00884838099265(21)59 (01)00884838099265(21)117 (01)00884838099258(21)197 (01)00884838099265(21)58 (01)00884838099265(21)18 (01)00884838099265(21)92 (01)00884838099258(21)144 (01)00884838099258(21)212 (01)00884838099265(21)42 (01)00884838099272(21)283 (01)00884838099241(21)82 (01)00884838085268(21)703810 (01)00884838099258(21)375 (01)00884838099241(21)170 (01)00884838099241(21)4 (01)00884838099272(21)118 (01)00884838099241(21)1534 (01)00884838099241(21)118 (01)00884838099258(21)358 (01)00884838099258(21)508 (01)00884838099258(21)499 (01)00884838099258(21)530 (01)00884838099272(21)203 (01)00884838099210(21)37 (01)00884838099258(21)549 (01)00884838099203(21)15 (01)00884838099258(21)348 (01)00884838085268(21)703461 (01)00884838099241(21)263 (01)00884838099241(21)263 (01)00884838099241(21)159 (01)00884838099241(21)160 (01)00884838099258(21)211 (01)00884838099258(21)474 (01)00884838099227(21)35 (01)00884838099241(21)309 (01)00884838099241(21)315 (01)00884838099241(21)110 (01)00884838099258(21)243 (01)00884838099258(21)610 (01)00884838099258(21)542 (01)00884838099241(21)305 (01)00884838099272(21)233 (01)00884838099272(21)88 (01)00884838099258(21)203 (01)00884838099258(21)604 (01)00884838099241(21)179 (01)00884838099210(21)73 (01)00884838099258(21)698 (01)00884838099258(21)703 (01)00884838099258(21)743 (01)00884838099234(21)65 (01)00884838099241(21)276 (01)00884838099210(21)87 (01)00884838099258(21)751 (01)00884838099272(21)276 (01)00884838099258(21)705 (01)00884838099258(21)701 (01)00884838099265(21)8 (01)00884838099272(21)21 (01)00884838099258(21)537 (01)00884838099258(21)779 (01)00884838099258(21)629 (01)00884838099258(21)631 (01)00884838099272(21)168 (01)00884838099258(21)423 (01)00884838099258(21)456 (01)00884838099258(21)302 (01)00884838099258(21)305 (01)00884838099258(21)310 (01)00884838099241(21)264 (01)00884838099258(21)249 (01)00884838099258(21)386 (01)00884838099258(21)506 (01)00884838099258(21)259 (01)00884838099258(21)248 (01)00884838099203(21)42 (01)00884838099241(21)302 (01)00884838099227(21)8 (01)00884838099227(21)9 (01)00884838099265(21)31 (01)00884838099265(21)87 (01)00884838099272(21)207 (01)00884838099265(21)140 (01)00884838099258(21)551 (01)00884838099203(21)23 (01)00884838099203(21)26 (01)00884838099272(21)178 (01)00884838099272(21)179 (01)00884838099241(21)115; Serial Numbers: 839 131 577 81 271 879 1783 1447 282 512 360 370 584 239 425 232 591 580 39 198 589 362 954 10 214 183 526 441 121 80 326 518 404 252 453 472 465 129 174 553 517 400 342 582 196 1391 485 262 277 120 703826 38 36 139 1199 940 945 947 703680 964 703724 703541 703815 991 1013 943 1025 417 511 559 560 340 45 703560 810 272 256 364 164 1250 226 860 1105 464 703523 703524 1418 1209 1427 703537 703538 703517 1426 395 139 1003 207 209 211 447 232 412 1547 59 92 1005 220 799 221 62 201 185 145 257 352 353 141 368 132 165 117 195 555 267 268 271 270 255 224 56 287 114 67 239 249 141 783 531 28 142 235 227 703959 600 348 176 634 321 123 32 72 8 64 46 91 2 4 95 283 21 22 295 140 5 6 7 74 218 38 40 15 166 47 48 13 140 9 49 20 157 597 810 171 413 76 304 48 27 270 52 416 45 291 535 86 576 345 198 126 457 117 241 510 86 60 76 168 157 137 893 473 77 20 397 73 107 392 30 137 11 67 210 64 77 142 80 166 70 28 75 192 193 27 57 692 110 34 91 200 43 161 69 61 63 157 184 13 46 59 117 197 58 18 92 144 212 42 283 82 703810 375 170 4 118 1534 118 358 508 499 530 203 37 549 15 348 703461 263 263 159 160 211 474 35 309 315 110 243 610 542 305 233 88 203 604 179 73 698 703 743 65 276 87 751 276 705 701 8 21 537 779 629 631 168 423 456 302 305 310 264 249 386 506 259 248 42 302 8 9 31 87 207 140 551 23 26 178 179 115 |
| Center Classification Date | 20220406 |
| Recall Initiation Date | 20220202 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Letter |
| Similar To |