PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC

Hazard

Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

Details from the source

Reason for recall: Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. Distribution: Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus Quantity: 13, 133 (3,408 US; 9,725 ROW) Lot/code info: Azurion 3 M12 722063 - UDI-DI 00884838085275 or 00884838086777 Serial Numbers 108 122 131 132 56 64 84 96 98 , 722221 - UDI-DI 00884838099203 Serial Numbers 19 3 6 7 9 ; Azurion 3 M15 722064 - UDI-DI 00884838085282 Serial Numbers 201 209 218 229 238 258 259 260 261 267 270 291 314 335 64 , 722222 - UDI-DI 00884838099210 Serial Numbers 12 15 17 19 23 ; Azurion 5 M20 722228 - UDI-DI 00884838099234 Serial Numbers 10 17 18 23 24 25 26 29 38 49 62 ; Azurion 7 B12 722067 - UDI-DI 00884838059290, 00884838064775, or 00884838085350 Serial Numbers 103 104 109 114 115 123 131 132 133 141 147 148 150 163 172 173 190 192 208 214 221 225 234 244 250 26 277 278 36 41 42 46 57 69 70 71 75 81 92 98 , 722225 - UDI-DI 00884838099265 Serial Numbers 28 29 37 41 53 72 ; Azurion 7 B20 722068 - UDI-DI 00884838059207, 00884838064775, 00884838085367, or 00884838101883 Serial Numbers 101 103 104 107 109 110 111 113 114 117 130 136 137 143 146 147 149 150 153 170 172 178 184 196 205 213 225 232 239 243 247 251 261 262 270 271 277 279 282 285 288 295 304 308 319 320 322 323 324 329 330 335 337 350 354 356 361 370 373 374 400 406 407 413 418 42 431 440 442 443 446 457 462 467 469 470 472 477 479 487 490 494 505 510 511 520 524 528 547 564 64 73 75 76 78 82 84 85 89 95 , 722226 - UDI-DI 00884838099272 or 00884838101883 Serial Numbers 100 105 107 108 11 112 113 117 120 121 122 123 124 125 126 127 129 139 143 144 147 153 159 173 174 180 181 19 220 255 59 67 75 78 98 ; Azurion 7 M12 722078 - UDI-DI 0088483808

UPC codes

00884838085275, 00884838086777, 00884838099203, 00884838085282, 00884838099210, 00884838099234, 00884838059290, 00884838064775, 00884838085350, 00884838099265, 00884838059207, 00884838085367, 00884838101883, 00884838099272, 00884838085251, 00884838101890, 00884838099241, 00884838059191, 00884838059221, 00884838085268, 00884838059184, 00884838099258

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.