United StatesPhilips Tempus Pro Patient Monitor (REF 00-1004, 00-1007, 00-1004‑R, 00-1007‑R, 00-1024‑R, 00-1026‑R) and its USB 2‑Channel IBP Module (REF 01‑2017), used with User/Operator Manual Version 41‑2001EN, are recalled; affected units include the REF/UDI‑DI numbers and serial numbers listed in the notice. The monitors’ intracranial pressure (ICP) and bladder pressure (BDR) measurements have not been tested or validated for accuracy, which could lead healthcare providers to make incorrect clinical decisions based on those measurements.
What's being recalled
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Recalling firm: Remote Diagnostic Technologies Ltd., Farnborough, United Kingdom.
How to identify it
REF/UDI-DI: 00-1004/05060472440624; 00-1007/05060472440655; 00-1004-R/05060472440020, 05060472442901; 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932; User/Operator Manual Version 41-2001EN Serial Numbers: 30264 616174 616689 616695 616701 616703 616706 615658 615668 615551 615552 615555 615556 615557 615559 602803 602941 603335 603342 603406 603407 603409 603410 603412 602157 602159 602160 602163 602164 602168 602169 602170 602171 602172 615637 616688 614764 615435 615526 615604 615606 615607 615623 603631 604118 604119 604120 604127 604130 604138 616466 602877 602895 616584 616581 603518 603529 603555 614730 614734 614736 614737 614958 614970 614971 614972 614973 616719 616720 616725 616727 616978 616432 30100 30201 30202 30203 616491 616492 616493 616494 616496 616500 616503 616456 600613 615937 616338 616380 616678 616679 616683 616685 616687 616702 616344 616351 616384 616604 616608 616614 616682 616690 616691 616825 603857 603858 603859 603860 603862 603863 603865 603868 603869 603870 603871 603872 603876 603877 603881 603883 603885 603892 603897 603901 603906 603907 603908 603909 603914 603915 603916 603917 603918 603919 603920 603921 603922 603923 603924 603925 603926 603927 603928 603929 615717 615719 615728 615729 615742 615860 615886 630322 630714 630679 631728 632096 632135 616480 616488 614532 614605 614752 615707 616991 616999 602639 614844 614759 614767 614769 614841 614856 614891 614893 614894 614896 615047 615048 615049 615050 615051 615052 615053 615055 614780 614276 614546 614548 614549 614550 614552 614553 614626 630653 630632 630643 630647 630358 630621 630340 630611 630617 630622 632137 602214 602217 601897 602423 603646 630150 630782 630803 630827 630835 615301 604063 604060 604093 604097 616465 614772 614774 614777 614815 614820 614821 630344 630625 630634 616375 616410 615481 600692 630033 630039 630111 630191 630218 630233 615290 615383 615393 615401 615411…
The hazard
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, IL, SG, CA, IE, TH, NL, MY, AT, DK, RO, CH, IS, PT, NO, HK, PL, KY, OM, CZ, SI, SL, GI, ZA, AF, SE, FI.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)