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 mo

Hazard

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

Details from the source

Reason for recall: During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues. 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, Quantity: 5,540 units Lot/code info: 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.

UPC codes

05060472440020, 05060472442901, 05060472440013, 05060472441027, 05060472442925, 05060472441058, 05060472442932

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.