Z-3253-2026Class II

nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT...

Name: Z-3253-2026 nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT...
Creator: Criticare Technologies, Inc.
Published: 2026-05-06
License: https://open.fda.gov/license/

Criticare Technologies, Inc. / initiated 2026-05-06 / Open, Classified

FDA source

Recall record

Recall number: Z-3253-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-06
Posted: 2026-09-22
Recalling firm: Criticare Technologies, Inc.
Product: 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
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3253-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3253-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-22

Product code MHX

K030613Class IIVital Signs Monitor W/arrhythmia Detection and St Analysis, Model 8100Criticare Systems, Inc. / cleared 2003-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)