St. Jude Medical: CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Whic

Hazard

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

Details from the source

Reason for recall: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and the countries of Australia, and Canada. Quantity: 605 units Lot/code info: MN6000 (Which interfaces with CM1100 for PES) UDI-DI Code: 05414734510035 Merlin ID / PES Serial Number: 027556711 CM1100 P180912371 444058655 CM1100 P240100658 494955560 CM1100 P230300384 497887091 CM1100 P180208671 513914390 CM1100 P230800825 742148364 CM1100 P220800695 751954397 CM1100 P211200289 000697912 CM1100 P181013064 001545862 CM1100 P220400808,P220100189 003473584 CM1100 P211100353 005842000 CM1100 P230100314 006333918 CM1100 P220600729 008418758 CM1100 P240300492 010473700 CM1100 P210700575 010485845 CM1100 P220100057 011307774 CM1100 P190800198 013397427 CM1100 P220500363 018103333 CM1100 P210201417 018852830 CM1100 P190900022 019716455 CM1100 P221100752 020956348 CM1100 P230500703 021148283 CM1100 P160900736 021410246 CM1100 P230800171 023874951 CM1100 P230400238 024386088 CM1100 P200100300 026473926 CM1100 P240500531 031880776 CM1100 P240300135 032455370 CM1100 P240300138 034701771 CM1100 P230300580 037825221 CM1100 P240100040 039458344 CM1100 P190700191 042069666 CM1100 P221200307 043804384 CM1100 P220401019 044375798 CM1100 P200100451 046139531 CM1100 P210400699 046659165 CM1100 P220700471 049107915 CM1100 P220600696 049584410 CM1100 P230800848 053752093 CM1100 P230900101 053919908 CM1100 P200600006 054799366 CM1100 P211100584 055804058 CM1100 P180912650 056345895 CM1100 P210200735 057332710 CM1100 P240100823 058913997 CM1100 P240100775 060968161 CM1100 P240200495 061420626 CM1100 P230500071 062897822 CM1100 P240300373 066957044 CM1100 P210700838 067353847 CM

UPC codes

05414734510035

Source

Official record: FDA (Device enforcement) ↗

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