HAMILTON C2 Ventilator Is intended to provide positive pressure… — Class I medical device recall Z-2141-2023
Ongoing recall by Hamilton Medical, Inc., reported 2023-08-02, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the
| Recall number | Z-2141-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical, Inc., Reno, NV, United States |
| Recall initiated | 2023-06-15 |
| Classified | 2023-07-21 |
| Reported by FDA | 2023-08-02 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | BS, JP, MX |
| Quantity | 399 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07630002800372 |
| Serial numbers | 10080, 10081, 10082, 10083, 10085, 10089, 10090, 10092, 10093, 10095, 10096, 10097, 10098, 10099, 10102, 10103, 10104, 10112, 10116, 10118, 10119, 10120, 10122, 10123, 10129 and 317 more |
| Model numbers | 160001, HAMILTON-C2 |
Product
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Reason for recall
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2141-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.