Company: Remote Diagnostic Technologies Ltd.
Date of Enforcement Report: 5/7/2025
Class II
PRODUCT
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Recall Number:
Z-1729-2025
REASON:
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
RECALLING FIRM/MANUFACTURER:
Remote Diagnostic Technologies Ltd.
VOLUME:
6961
DISTRIBUTION:
Worldwide – US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, , MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE, DC and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, IL, SG, CA, IE, TH, NL, MY, AT, DK, RO, CH, IS, PT, NO, HK, PL, KY, OM, CZ, SI, SL, ZA, AF, SE, FI
