Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Summary
The FDA issued a Class II for Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 by Remote Diagnostic Technologies Ltd.. Reason: Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffectiv.
Details
Source
Device Recall
External ID
Z-1825-2023
Action Date
2023-06-21
Status
Ongoing
Category
device
Product Description
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Lot/Code Info: UDI-DI: 07613365002737. Serial numbers prior to 7022.001634
Quantity Affected: 1147
Reason for Recall
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".
Distribution
US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-08
Company
Farnborough, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remote Diagnostic Technologies Ltd. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Remote Diagnostic Technologies Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remote Diagnostic Technologies Ltd. have FDA actions?
Remote Diagnostic Technologies Ltd. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1825-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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