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U.S. Department of Health and Human Services

Class 2 Device Recall nGenuity Patient Monitor with Capnography

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 Class 2 Device Recall nGenuity Patient Monitor with Capnographysee related information
Date Initiated by FirmMay 06, 2026
Date PostedSeptember 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3253-2026
Recall Event ID 99545
510(K)NumberK030613 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductnGenuity 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 Information 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
FEI Number 3012238587
Recalling Firm/
Manufacturer		 Criticare Technologies, Inc.
333 Strawberry Field Rd Ste 11
Warwick RI 02886-2459
For Additional Information ContactService
401-667-3837
Manufacturer 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 Determined
Cause 2		Process design
ActionFirm 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 Commerce1,007
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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