Remote Diagnostic Technologies Ltd. recalls Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
Read the official notice →- Date
- 2023-06-21
- Country
- United States
- Brand
- Remote Diagnostic Technologies
- Product
- Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
- Classification
- Class II
- Units
- US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-04-30
USRemote 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 → - 2023-04-12
- US
Remote Diagnostic Technologies Ltd. recalls Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified…
During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide Distribution: U.S.(nationwide): AL, AZ, CA, CO, DC, DE, FL, GA, HI,…Official notice → - 2022-04-13
- US
Remote Diagnostic Technologies Ltd. recalls Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
FDA · DeviceRemote Diagnostic Technologies Ltd.US Nationwide distribution in the states of IL and KS.Official notice →
Other drugs & medical recalls in the United States
- 2023-06-21
- US
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice → - US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
- US
Ossur H / F recalls Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption…
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the…
FDA · DeviceOssur H / FUS: SC, FL,NM, PA, VA, CA, TX, MT, UT, OH, NV, KS, MI, GA, IA, WA, TN, AZ, MN,…Official notice → - US
New Standard Device Inc recalls 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
The threads on posts stripping out when tensioned during application process.
FDA · DeviceNew Standard Device IncU.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.Official notice → - US
Apothecary Products, LLC recalls Eye and Ear Dropper, Product Code 67082
Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.
FDA · DeviceApothecary Products, LLCWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice → - US
p-Chip Corporation recalls p-Chip Wand Reader
The laser operation might fall under a higher laser class.