Recall Z-3253-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Criticare Technologies, Inc.
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
| Date | Sep 22, 2026 (initiated May 6, 2026) |
| Status | Open, Classified |
| 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 |
| 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. |
| Quantity | 1,007 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030613 | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 Criticare Systems, Inc., Apr 17, 2003 |