FDAFDA · Food and drugs·Recall number Z-1315-2018
IntelliVue X3 Patient Monitor.
Published April 18, 2018 · Recall initiated: November 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Electronics North America Corporation
- Distributor
- 48 Foreign Accounts
- Lot
- Model 867030 - All devices shipped from June 2017 (Updated 8-14-18) Serial No. DE61102743 DE61103908 DE61102877 DE61105176 DE61102652 DE61102659 DE61104847 DE61101457 DE61101460 DE61100472 DE61101176 DE61100535 DE61100101 DE61100544 DE61101308 DE61101569 DE61101001 DE61101266 DE61100411 DE61101279 DE61101110 DE61100173 DE61101283 DE61100511 DE61100153 DE61101302 DE61101480 DE61100832 DE61100139 DE61100176 DE61100845 DE61100201 DE61100558 DE61100243 DE61100466 DE61100240 DE61100293 DE61100678 DE61100910 DE61100202 DE61101132 DE61100561 DE61100172 DE61101010 DE61101158 DE61101409 DE61101427 DE61101218 DE61100700 DE61100526 DE61101004 DE61100927 DE61101441 DE61100755 DE61100753 DE61101456 DE61101462 DE61101463 DE61101464 DE61101465 DE61101466 DE61101470 DE61101471 DE61101475 DE61101476 DE61101478 DE61101479 DE61101481 DE61101483 DE61101484 DE61101486 DE61101487 DE61101489 DE61101494 DE61101496 DE61101501 DE61101507 DE61101508 DE61101512 DE61101516 DE61101521 DE61100469 DE61101172 DE61101178 DE61101180 DE61101181 DE61101182 DE61101184 DE61101185 DE61101188 DE61101189 DE61101190 DE61101194 DE61101196 DE61101197 DE61101198 DE61101199 DE61101201 DE61101203 DE61101204 DE61101205 DE61101206 DE61101207 DE61101208 DE61101209 DE61101210 DE61101211 DE61101212 DE61101213 DE61101214 DE61101216 DE61101221 DE61101229 DE61101232 DE61101233 DE61101235 DE61101236 DE61101239 DE61101240 DE61101241 DE61101244 DE61101246 DE61101247 DE61101248 DE61101249 DE61101251 DE61101252 DE61101253 DE61101254 DE61101255 DE61101256 DE61101259 DE61101260 DE61101261 DE61101262 DE61101263 DE61101264 DE61101268 DE61101269 DE61101270 DE61101271 DE61101272 DE61100534 DE61100538 DE61100539 DE61100542 DE61100543 DE61100563 DE61100565 DE61100658 DE61100659 DE61100695 DE61100698 DE61100100 DE61100102 DE61100103 DE61100104 DE61100106 DE61100107 DE61100109 DE61100110 DE61100111 DE61100113 DE61100114 DE61100115 DE61100116 DE61100117 DE61100118 DE61100119 DE61100120 DE61100121 DE61100122 DE61100123 DE61100124 DE61100125 DE61100127 DE61100128 DE61100130 DE61100131 DE61100132 DE61100134 DE61100135 DE61100136 DE61100144 DE61100147 DE61100536 DE61100545 DE61100546 DE61100547 DE61100548 DE61100549 DE61100551 DE61100552 DE61100553 DE61100555 DE61100569 DE61100573 DE61100579 DE61100580 DE61100586 DE61100587 DE61100588 DE61100589 DE61100590 DE61100593 DE61100595 DE61100597 DE61100598 DE61100599 DE61100600 DE61100601 DE61100602 DE61100603 DE61100628 DE61100629 DE61100630 DE61100634 DE61100643 DE61101173 DE61101542 DE61101588 DE61101590 DE61101591 DE61101000 DE61101012 DE61101013 DE61101016 DE61101035 DE61101265 DE61100410 DE61100412 DE61100415 DE61100418 DE61100421 DE61100427 DE61100430 DE61100431 DE61100440 DE61100475 DE61100482 DE61100483 DE61100484 DE61100486 DE61100488 DE61100491 DE61100494 DE61100495 DE61100497 DE61100499 DE61100500 DE61100502 DE61100505 DE61100507 DE61100578 DE61101497 DE61101500 DE61101276 DE61101282 DE61101289 DE61101290 DE61101291 DE61101296 DE61101297 DE61101347 DE61101363 DE61101109 DE61101113 DE61101117 DE61101119 DE61101124 DE61101125 DE61101136 DE61101139 DE61101165 DE61100170 DE61100181 DE61101278 DE61101285 DE61101287 DE61101325 DE61101328 DE61101330 DE61101331 DE61101332 DE61101333 DE61101335 DE61101337 DE61101341 DE61101348 DE61101349 DE61101350 DE61101351 DE61101352 DE61101353 DE61101354 DE61101355 DE61101356 DE61101357 DE61101358 DE61101359 DE61101360 DE61101361 DE61101362 DE61101364 DE61101365 DE61101366 DE61101369 DE61101373 DE61101374 DE61101377 DE61101379 DE61101380 DE61101382 DE61101384 DE61101385 DE61101386 DE61101388 DE61101390 DE61101391 DE61101392 DE61101393 DE61101395 DE61101396 DE61101399 DE61101401 DE61101406 DE611014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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