Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R,
Summary
The FDA issued a Class II for Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Par by Remote Diagnostic Technologies Ltd.. Reason: The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged..
Details
Source
Device Recall
External ID
Z-1997-2021
Action Date
2021-07-07
Status
Ongoing
Category
device
Product Description
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
Lot/Code Info: Software version number: v07.00, v07.01, v07.18, v07.20, v07.22, v07.24. UDI No. 12NC No. 05060472440020 989706002081 05060472440013 989706000001 05060472441027 989706000051 05060472441058 989706000101
Quantity Affected: 510 systems
Reason for Recall
The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, TX, PA, MN, UT, MT, CA, WI, VA, NY, TN, KS, MD and the countries of Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-25
Company
Basingstoke, 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 52 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-1997-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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