FDA DevicesClass II
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R,...
Published: January 14, 2026Recall ID: Z-1027-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Farnborough |
| Event id | 97889 |
| Address 1 | Farnborough Aerospace Centre |
| Address 2 | Aerospace Boulevard |
| 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... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 7129 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251126 |
| Initial firm notification | Letter |
| Center classification date | 20260108 |
Overview
- Recalling FirmRemote Diagnostic Technologies Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.