nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100…
Criticare Technologies, Inc. · Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
Open FDA's page for this record- Cfres ID
- 221806
- Product res number
- Z-3253-2026
- Event date initiated
- 2026-05-06
- Event date posted
- 2026-09-22
- Recall status
- Open, Classified
- Res event number
- 99545
- Product code
- MHX
- Product description
- 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
- 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
- Firm FEI number
- 3012238587
- Recalling firm
- Criticare Technologies, Inc.
- Address 1
- 333 Strawberry Field Rd Ste 11 333 Strawberry Field Rd
- Address 2
- Ste 11
- City
- Warwick
- State
- RI
- Postal code
- 02886-2459
- Additional info contact
- Service 401-667-3837
- Reason for recall
- Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
- Root cause description
- Process design
- Product quantity
- 1,007
- Action
Firm posted its initial notice on May 6, 2026. A follow-up letter was sent on August 31, 2026 with additional instructions. Customers were instructed to do the following: 1. Be aware of the Checkline Error alarm. If it appears on your CO2 section at startup, follow the steps provided in the letter. 2. Verify your backup plan. Confirm that your practice has access to an alternate CO2 monitoring source. 3. Retain the letter and note your unit s serial number for your records. 4. Contact the firm if you have any questions.
- Distribution pattern
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.
- K numbers
- K030613
- Harmonized identifiers (openFDA)
- Device name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1025
- Device class
- 2
- K number
- K131872, K050141, K131032, K092970, K982279, K062095, K073550, K080157, K090702, K083271, K210906, K062324, K151063, K950264, K151860, K990476, K203435, K101067, K141015, K062194, K070588, K041741, K060541, K983996, K030431, K051400, K073280, K993608, K023475, K172510, K043439, K003248, K203088, K191149, K041790, K221616, K250757, K001433, K040357, K001348 +390 more
- Registration number
- 3009443693, 1316463, 8022257, 3010536822, 3019545235, 3006606827, 3030597679, 8030978, 3012238587, 3011353843, 3001570235, 3009673645, 3012972516, 3021736577, 9610105, 3004415095, 3011120183, 3013679558, 3020115, 3007836437, 3004196561, 1218950, 3003263092, 3007481893, 3013596024, 3021219789, 3010611950, 3021559257, 3005521864, 3003589956, 3004526608, 3030446844, 3003971136, 3008363989, 3008642652, 3010882708, 3007413079, 3022123357, 3007305624, 2032233 +80 more
- FEI number
- 3009443693, 1316463, 3010536822, 3019545235, 3006606827, 3030597679, 3012238587, 3011353843, 3001570235, 3009673645, 3012972516, 3021736577, 3004415095, 3011120183, 3013679558, 3020115, 3007836437, 3004196561, 3000957797, 1218950, 3003263092, 3007481893, 3013596024, 3021219789, 3010611950, 3021559257, 3005521864, 3003589956, 3004526608, 3030446844, 3003971136, 3008363989, 3008642652, 3010882708, 3003757840, 3007413079, 3007305624, 3006147705, 3004977335, 3013501110 +80 more