Device recall
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
- Recall number
- Z-3253-2026
- Event id
- 99545
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Criticare Technologies, Inc.
- Report date
- Sep 30, 2026
- Posted
- Sep 22, 2026
- Initiated
- May 6, 2026
- Center classification date
- Sep 22, 2026
- Product code
- MHX
- Device type
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Reason
- Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
- Root cause
- Process design
- Quantity
- 1,007
- Code info
- UDI-DI +B4388100EP1US02 All units with CO2 option SN beginning with 424, 125, 225, 325, 425, 126, 226, 326, 426, date range 2024-1st qt 2026
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K030613
- Location
- Warwick, RI, United States