Recall Z-1321-2023 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Remote Diagnostic Technologies Ltd.
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
| Date | Apr 1, 2023 (initiated Feb 23, 2023) |
| Status | Open, Classified |
| Reason | During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues. |
| Root cause | Under Investigation by 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 Tak |
| Quantity | 5,540 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201746 | Tempus Pro Patient Monitor Remote Diagnostic Technologies Limited, Sep 18, 2020 |