FDA-Device2026-09-30Class IIPROCESSING DEFECT
Criticare nGenuity Patient Monitor with Capnography recalled for CO2 monitoring failure
What this means
Some Criticare nGenuity Patient Monitors with CO2 monitoring display a "Checkline Error" alarm during setup, which disables the CO2 monitoring function. This may delay medical procedures that rely on this monitoring capability.
- Contact Criticare Technologies if you operate an affected unit (serial numbers beginning with 424, 125, 225, 325, 425, 126, 226, 326, or 426, manufactured between Q1 2024 and Q1 2026)
- Do not rely on the CO2 monitoring function if you encounter the Checkline Error
- Follow your facility's protocol for alternative monitoring during procedures
The agency's original wording
Hazard
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution including in the states and territory of AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and Puerto Rico.
Affected count
1,007
Manufactured in
333 Strawberry Field Rd Ste 11, Warwick, RI, United States
Products
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3253-2026Want us to check the next one for you?
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