Tempus Pro recallZ-1321-2023 · Remote Diagnostic Technologies Ltd. · initiated Feb 23, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remote Diagnostic Technologies Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
FDA root cause category: Under Investigation by firm
What the company is doing
On 02/17/2023, the firm sent an "URGENT Medical Device Correction" Letter via priority mail to customers informing them that during internal testing, Regulatory Compliance issues regarding Fluid Ingress and Basic Safety issues were identified with the Tempus Pro Monitor, AC Mains Power Supply, and the Vehicle Adaptor. Customers are instructed to: " As there is currently no indication that any of the issues have resulted in a degradation in product performance, Philips advises that the Tempus Pro devices should remain in service. " Continue to follow the User/Operator Manual, including: o Take care to ensure that water or liquids are not spilt over the device or into its ventilation holes in the side corners. o Check connector covers, particularly the capnometer door cover, to ensure they close and latch acceptably. " Post this Urgent Medical Device Correction letter on or near your Tempus Pro device. " Complete and return the Urgent Medical Device Correction response form included, no later than 30 days from receipt. Philips will be providing a new and compliant AC Mains Power Supply to all affected customers. A new and compliant Vehicle Adaptor will also be provided to affected customers with devices that include that option. Philips anticipates providing this solution to customers in the second half of 2023. For questions or further information, contact the local Philips Representative, or Philip at (800)263-3342.
Recall details
- Recall number
- Z-1321-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 23, 2023
- Posted by the FDA
- Apr 1, 2023
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Quantity
- 5,540 units
- Product code
- MHX
- FDA submissions
- K201746
- Distribution
- Worldwide Distribution: U.S.(nationwide): AL, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and O.U.S.(foreign): United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Brunei Darussalam, Bolivia, Canada, Switzerland, Czechia, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Cayman Islands, Luxembourg, Malaysia, Netherlands, Norway, Portugal, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Mayotte, and South Africa.
Product description
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Code information (models, lots, serial numbers)
Model Numbers: 00-1004 00-1004-R UDI-DI Codes: 05060472440020 05060472442901 00-1007 00-1007-R UDI-DI Codes: 05060472440013 05060472442901 00-1024-R UDI-DI Codes: 05060472441027 05060472442925 00-1026-R UDI-DI Codes: 05060472441058 05060472442932 Lot Codes - All products manufactured are affected.
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- Tempus Pro 00-1026-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls1 death324 reports
- Tempus Pro 00-1007-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls114 reports
- Tempus Pro 00-1004-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)6 recalls36 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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