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
FDA Recall Z-3253-2026 · Posted 2026-09-22
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Recalling FirmCriticare Technologies, Inc.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2026-05-06
Product Quantity1,007
Reason for Recall
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
Firm 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.
Root Cause
Process design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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