Class II U.S. Food and Drug Administration

Remote Diagnostic Technologies Ltd. Philips Tempus Pro recall: Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure

Recall published 9 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1027-2026
Published
January 14, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Remote Diagnostic Technologies Ltd.
Product type
Medical devices
Units affected
7129
Distribution
Nationwide
Made in
United Kingdom
Lot / code info
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 615413 615433 615434 615436 602165 602177 602194 602205 616455 604150 614281 615087 604047 615057 615058 615070 615074 615077 615078 615079 615080 615081 615446 615114 615116 615221 615222 615223 615224 615225 615226 615227 616937 30093 30094 30096 30098 30099 600062 600063 600696 601984 602448 616490 616508 616510 600698 600731 602521 615999 616002 616007 616026 616031 40105 603823 603660 603831 603835 603836 603850 603849 615549 614888 615730 615132 615231 615235 602049 602444 615615 616295 616306 616308 616309 616311 616315 616317 616318 616321 616346 616348 616352 616363 616364 616385 616398 616404 616408 616411 616413 616415 616429 616436 616437 616446 616448 616449 616450 616452 616454 616457 616458 616459 616462 616464 616467 616471 616473 616474 616475 616477 616478 616479 616481 616483 616485 616487 616616 616617 616618 616619 616623 616627 616628 616630 616633 616634 616635 616636 616637 616638 616640 616642 616645 616647 616656 616658 616659 616660 616662 616666 616668 602317 601950 602431 602051 614802 614370 614392 603700 603701 603703 603705 603707 603712 603719 603723 603724 614718 615562 615590 615698 615402 615412 615418 615420 614940 614941 614944 615399 615405 615408 615409 616712 616714 616738 616743 616745 616747 616749 602046 602047 602048 616586 616587 616676 616696 616717 616718 616723 616726 616728 616730 616740 616742 40141 40140 603847 603852 615565 616037 616036 602079 602464 602545 30220 30221 30222 30223 30224 30225 30226 30228 30229 30232 30233 30234 30235 30236 30237 30238 30244 30227 617009 614854 614927 615228 615229 615230 615232 615233 615234 616580 602409 601915 602041 614750 614790 615558 630792 615864 615865 601977 604094 604107 614573 602083 602103 604106 601969 600053 600054 600368 600827 600831 600832 602062 602428 603837 603841 40127 40142 602218 602506 602515 40199 40200 600611 630148 630149 630161 630162 630178 630190 630204 630739 630743 630752 630781 630799 630806 630810 630829 630830 630832 630833 631040 631041 631044 631051…
UPC codes
05060472440624, 05060472440655, 05060472440020, 05060472442901, 05060472440013, 05060472442918, 05060472441027, 05060472442925, 05060472441058, 05060472442932

Products covered by this recall

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

Check your product

The notice names 17 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05060472440624
  • 05060472440655
  • 05060472440020
  • 05060472442901
  • 05060472440013
  • 05060472442918
  • 05060472441027
  • 05060472442925
  • 05060472441058
  • 05060472442932

Model or item number

On the rating label, the box or the instruction sheet.

  • 00-1004
  • 00-1007
  • 00-1004-R
  • 00-1007-R
  • 00-1024-R
  • Operator Manual — REF
  • UDI-D

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Remote Diagnostic Technologies Ltd. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Remote Diagnostic Technologies Ltd. — Farnborough Aerospace Centre, Farnborough

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Remote Diagnostic Technologies Ltd. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05060472440624, 05060472440655, 05060472440020; model number 00-1004, 00-1007, 00-1004-R. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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