Remote Diagnostic Technologies Ltd. recalls 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…
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…
Read the official notice →- Date
- 2026-01-14
- Country
- United States
- Brand
- Remote Diagnostic Technologies
- Product
- 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:…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AZ, VA, FL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Remote Diagnostic Technologies recalls
- 2025-08-06
USRemote Diagnostic Technologies Ltd. recalls Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an…
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead…
FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and…Official notice →- 2025-05-14
- US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May…
FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide - US Nationwide distribution including in the states of AZ, VA, FL,…Official notice → - 2025-04-30
- US
Remote Diagnostic Technologies Ltd. recalls Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007…
software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide - US Nationwide distribution including in the states of AL, AZ, CA,…Official notice → - 2024-12-04
- US
Remote Diagnostic Technologies Ltd. recalls Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or…
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
FDA · DeviceRemote Diagnostic Technologies Ltd.U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.Official notice → - 2024-06-12
- US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may…
FDA · DeviceRemote Diagnostic Technologies Ltd.US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL,…Official notice → - 2023-09-27
- US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With…
Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required.…
FDA · DeviceRemote Diagnostic Technologies Ltd.US:AZ, AL, CA, CO, DC, DE, FL , GA, HI, IA, ID, IL, IN , KS, KY, MA , MD , ME,…Official notice →
Other drugs & medical recalls in the United States
- 2026-01-14
- US
Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
FDA · DeviceAbiomed, Inc.International distribution to the country of Australia and Taiwan.Official notice → - US
Sophysa recalls The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Customer complaints of Pressio monitor rebooting.
FDA · DeviceSophysaUS Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01,…
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK,AL,AR,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs,…
FDA · DeviceBeckman Coulter, Inc.Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - US
Meridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
The affected lots show a decline in performance over time, which may lead to false-negative results.
FDA · DeviceMeridian Bioscience IncUS Nationwide distribution and the OUS country of Italy.Official notice → - US
Applied Medical Resources Corp recalls Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
FDA · DeviceApplied Medical Resources CorpUS: MI, CA, ME, OUS: France Great Britain, GermanyOfficial notice →