Philips North America Llc Recall 88854
Description: Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
Philips North America Llc Recall 88854 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0213-2022 |
Event ID | 88854 |
Event Description | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20) |
Product Type | Devices |
Distribution | Domestic distribution nationwide. International distribution worldwide. |
Quantity | 428 (US); 581 (OUS) |
Recall Reason | When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable. |
Device Classification | 20211117 |
Device Code Info | Software version 2.1.x Serial Number | Unique Device Identifier (UDI#) 140 (01)00884838099258(21)140 124 (01)00884838099241(21)124 75 (01)00884838099258(21)75 824 (01)00884838085251(21)824 182 (01)00884838099258(21)182 703416 (01)00884838085268(21)703416 626 (01)00884838085251(21)626 697 (01)00884838085251(21)697 3 (01)00884838099203(21)3 703368 (01)00884838085268(21)703368 139 (01)00884838099258(21)139 159 (01)00884838099258(21)159 36 (01)00884838099241(21)36 266 (01)00884838099258(21)266 512 (01)00884838099258(21)512 703413 (01)00884838085268(21)703413 1410 (01)00884838085268(21)1410 703329 (01)00884838085268(21)703329 250 (01)00884838099258(21)250 226 (01)00884838099258(21)226 105 (01)00884838099272(21)105 360 (01)00884838099258(21)360 370 (01)00884838099258(21)370 1379 (01)00884838085268(21)1379 452 (01)00884838099258(21)452 141 (01)00884838085251(21)141 279 (01)00884838085251(21)279 644 (01)00884838085251(21)644 455 (01)00884838085268(21)455 48 (01)00884838099234(21)48 584 (01)00884838099258(21)584 239 (01)00884838099272(21)239 34 (01)00884838099258(21)34 131 (01)00884838099241(21)131 88 (01)00884838099258(21)88 890 (01)00884838085251(21)890 15 (01)00884838099210(21)15 19 (01)00884838099210(21)19 919 (01)00884838085268(21)919 33 (01)00884838099258(21)33 792 (01)00884838085268(21)792 469 (01)00884838085367(21)469 53 (01)00884838099258(21)53 469 (01)00884838085367(21)469 363 (01)00884838099258(21)363 409 (01)00884838099258(21)409 260 (01)00884838085282(21)260 261 (01)00884838085282(21)261 132 (01)00884838085275(21)132 17 (01)00884838099234(21)17 658 (01)00884838085268(21)658 425 (01)00884838099258(21)425 308 (01)00884838085367(21)308 189 (01)00884838099258(21)189 32 (01)00884838099234(21)32 131 (01)00884838085275(21)131 225 (01)00884838099258(21)225 235 (01)00884838099258(21)235 50 (01)00884838099258(21)50 209 (01)00884838085282(21)209 69 (01)00884838099241(21)69 23 (01)00884838099234(21)23 25 (01)00884838099234(21)25 107 (01)00884838099272(21)107 172 (01)00884838085367(21)172 29 (01)00884838085268(21)29 391 (01)00884838099258(21)391 769 (01)00884838085268(21)769 938 (01)00884838085268(21)938 171 (01)00884838099241(21)171 29 (01)00884838099234(21)29 369 (01)00884838099258(21)369 108 (01)00884838085275(21)108 103 (01)00884838099258(21)103 220 (01)00884838099258(21)220 271 (01)00884838099258(21)271 218 (01)00884838099258(21)218 108 (01)00884838099258(21)108 513 (01)00884838085251(21)513 164 (01)00884838099258(21)164 9 (01)00884838099203(21)9 23 (01)00884838099210(21)23 232 (01)00884838099258(21)232 100 (01)00884838099258(21)100 1412 (01)00884838085268(21)1412 385 (01)00884838099258(21)385 460 (01)00884838085268(21)460 1387 (01)00884838085268(21)1387 260 (01)00884838099258(21)260 153 (01)00884838099272(21)153 499 (01)00884838085268(21)499 1230 (01)00884838085268(21)1230 709 (01)00884838085251(21)709 649 (01)00884838085251(21)649 703510 (01)00884838085268(21)703510 112 (01)00884838099258(21)112 703334 (01)00884838085268(21)703334 161 (01)00884838099241(21)161 92748035 (01)00884838099241(21)92748035 113 (01)00884838099258(21)113 53 (01)00884838099265(21)53 49 (01)00884838099258(21)49 436 (01)00884838099258(21)436 45 (01)00884838099258(21)45 441 (01)00884838085251(21)441 39 (01)00884838099258(21)39 703558 (01)00884838085268(21)703558 12 (01)00884838099210(21)12 198 (01)00884838099241(21)198 703324 (01)00884838085268(21)703324 42 (01)00884838099258(21)42 703435 (01)00884838085268(21)703435 76 (01)00884838099258(21)76 109 (01)00884838085367(21)109 24 (01)00884838099234(21)24 335 (01)00884838099258(21)335 413 (01)00884838085367(21)413 56 (01)00884838099258(21)56 350 (01)00884838099258(21)350 587 (01)00884838099258(21)587 119 (01)00884838099258(21)119 180 (01)00884838099272(21)180 129 (01)00884838099258(21)129 84 (01)00884838099258(21)84 43 (01)00884838099258(21)43 362 (01)00884838099258(21)362 210 (01)00884838099258(21)210 327 (01)00884838099258(21)327 124 (01)00884838099258(21)124 125 (01)00884838099258(21)125 1401 (01)00884838085268(21)1401 192 (01)00884838099258(21)192 10 (01)00884838099234(21)10 19 (01)00884838099203(21)19 455 (01)00884838085367(21)455 224 (01)00884838099258(21)224 239 (01)00884838099258(21)239 857 (01)00884838085268(21)857 134 (01)00884838099258(21)134 1411 (01)00884838085268(21)1411 1411 (01)00884838085268(21)1411 49 (01)00884838099234(21)49 381 (01)00884838099258(21)381 252 (01)00884838099258(21)252 139 (01)00884838099272(21)139 703501 (01)00884838085268(21)703501 703515 (01)00884838085268(21)703515 322 (01)00884838085367(21)322 803 (01)00884838085251(21)803 1231 (01)00884838085268(21)1231 1402 (01)00884838085268(21)1402 554 (01)00884838099258(21)554 703391 (01)00884838085268(21)703391 28 (01)00884838099265(21)28 228 (01)00884838099258(21)228 433 (01)00884838099258(21)433 99 (01)00884838099258(21)99 217 (01)00884838099258(21)217 78 (01)00884838099272(21)78 115 (01)00884838099258(21)115 68 (01)00884838099265(21)68 440 (01)00884838085367(21)440 291 (01)00884838099258(21)291 332 (01)00884838099258(21)332 373 (01)00884838085367(21)373 187 (01)00884838099258(21)187 441 (01)00884838099258(21)441 44 (01)00884838099210(21)44 278 (01)00884838099258(21)278 1385 (01)00884838085268(21)1385 1386 (01)00884838085268(21)1386 121 (01)00884838099272(21)121 80 (01)00884838099258(21)80 833 (01)00884838085251(21)833 183 (01)00884838099258(21)183 366 (01)00884838099258(21)366 101 (01)00884838099258(21)101 564 (01)00884838099258(21)564 374 (01)00884838099258(21)374 396 (01)00884838099258(21)396 482 (01)00884838099258(21)482 91 (01)00884838099258(21)91 120 (01)00884838099258(21)120 79 (01)00884838099258(21)79 703396 (01)00884838085268(21)703396 180 (01)00884838099241(21)180 703426 (01)00884838085268(21)703426 6 (01)00884838099203(21)6 72 (01)00884838099258(21)72 29 (01)00884838099265(21)29 703426 (01)00884838085268(21)703426 19 (01)00884838099272(21)19 82 (01)00884838099258(21)82 100 (01)00884838099272(21)100 326 (01)00884838099258(21)326 703336 (01)00884838085268(21)703336 329 (01)00884838099258(21)329 339 (01)00884838099258(21)339 921 (01)00884838085251(21)921 166 (01)00884838099258(21)166 703344 (01)00884838085268(21)703344 308 (01)00884838099258(21)308 307 (01)00884838099258(21)307 592 (01)00884838099258(21)592 77 (01)00884838099241(21)77 1355 (01)00884838085268(21)1355 1414 (01)00884838085268(21)1414 703387 (01)00884838085268(21)703387 703404 (01)00884838085268(21)703404 404 (01)00884838099258(21)404 703317 (01)00884838085268(21)703317 127 (01)00884838099241(21)127 329 (01)00884838085367(21)329 684 (01)00884838085251(21)684 703540 (01)00884838085268(21)703540 490 (01)00884838099258(21)490 225 (01)00884838085350(21)225 47 (01)00884838099241(21)47 47 (01)00884838099258(21)47 234 (01)00884838099258(21)234 67 (01)00884838099241(21)67 215 (01)00884838099258(21)215 143 (01)00884838099272(21)143 829 (01)00884838085251(21)829 126 (01)00884838099241(21)126 165 (01)00884838099258(21)165 216 (01)00884838099258(21)216 1012 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(01)00884838099258(21)28 703310 (01)00884838085268(21)703310 234 (01)00884838085350(21)234 703314 (01)00884838085268(21)703314 679 (01)00884838085251(21)679 1310 (01)00884838085268(21)1310 190 (01)00884838099258(21)190 414 (01)00884838099258(21)414 154 (01)00884838099258(21)154 26 (01)00884838099234(21)26 395 (01)00884838099258(21)395 37 (01)00884838099265(21)37 840 (01)00884838085251(21)840 354 (01)00884838099258(21)354 703493 (01)00884838085268(21)703493 443 (01)00884838085367(21)443 98 (01)00884838099272(21)98 844 (01)00884838085251(21)844 876 (01)00884838085251(21)876 29 (01)00884838099241(21)29 78 (01)00884838099258(21)78 795 (01)00884838085268(21)795 267 (01)00884838099258(21)267 268 (01)00884838099258(21)268 703495 (01)00884838085268(21)703495 346 (01)00884838099258(21)346 631 (01)00884838085268(21)631 1431 (01)00884838085268(21)1431 59 (01)00884838099272(21)59 18 (01)00884838085268(21)18 253 (01)00884838099258(21)253 105 (01)00884838099241(21)105 298 (01)00884838099258(21)298 286 (01)00884838099258(21)286 289 (01)00884838099258(21)289 703407 (01)00884838085268(21)703407 314 (01)00884838085282(21)314 131 (01)00884838099258(21)131 312 (01)00884838099258(21)312 40 (01)00884838099258(21)40 129 (01)00884838099272(21)129 67 (01)00884838099272(21)67 197 (01)00884838099272(21)197 174 (01)00884838099272(21)174 279 (01)00884838099258(21)279 104 (01)00884838099258(21)104 251 (01)00884838099258(21)251 490 (01)00884838085367(21)490 703418 (01)00884838085268(21)703418 250 (01)00884838085350(21)250 151 (01)00884838099258(21)151 87 (01)00884838099241(21)87 288 (01)00884838099258(21)288 117 (01)00884838099272(21)117 153 (01)00884838099258(21)153 219 (01)00884838099258(21)219 301 (01)00884838099258(21)301 703478 (01)00884838085268(21)703478 331 (01)00884838099258(21)331 110 (01)00884838099258(21)110 17 (01)00884838099210(21)17 163 (01)00884838099258(21)163 703409 (01)00884838085268(21)703409 240 (01)00884838099258(21)240 221 (01)00884838085350(21)221 703311 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Center Classification Date | 20211109 |
Recall Initiation Date | 20210924 |
Recalling Firm | Philips North America Llc |
Initial Notification | Letter |
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