Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified p
FDA device recall Z-1321-2023 · posted 2023-04-01 · Open, Classified
Recall details
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Reason for recall
- During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 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
- Date initiated
- 2023-02-23
- Date posted
- 2023-04-01
- Location
- Farnborough, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tempus Pro Patient Monitor (K201746) | Remote Diagnostic Technologies Limited | 2020-09-18 |