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Open, Classified

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

FDA Recall Z-1321-2023 · Posted 2023-04-01

Recalling FirmRemote Diagnostic Technologies Ltd.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2023-02-23
Product Quantity5,540 units

Reason for Recall

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020-09-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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