# FDA recall Z-1874-2019

> **Hamilton Medical AG** · Class I · device recall initiated 2019-03-25.

## Product

HAMILTON-G5, with software versions less than or equal to 2.60    The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.

## Reason for recall

New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.

## Distribution

Worldwide Distribution- US (Nationwide Distribution): MI, WI, OR, MO, TX, NV, PA, SC, HI, MN, ND, NC, AZ, FL, CA, MA, GA, NY, VA, WA, IN, CO, LA, IL, OH, TN, SD, OK, MI, AR, C, AK, WV, NJ, IA, NE, KS, MT, NH, AL, MD, KY, CT,  and RI.  And (International Distribution): AT, BE, BG, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IT, MT, NL. NO, PL.PT, RO, SE, SI, SK, TR, HR. AGO, ARE, ARM, AUS, AZE, BGD, BHR , BLR, BOL, BRA, CAN, CHL, CHN, COL, CRI, DOM, DZA, ECU, EGY, EST, HKG, IDN, IND, IRQ, ISR, JOR, JPN, KAZ, KOR, KWT, LBN, LBY, LKA, LVA, MAR, MDA, MDV, MEX, MNG, MYS, NPL, NZL, OMN, PAK, PAN, PER, PHL, PRI, PSE, QAT, RUS, SAU, SGP, SUR, SYR, THA, TUN, TWN, UKR, URY, USA, VEN, VNM, YEM,  and ZAF.

## Key facts

- **Recall number:** Z-1874-2019
- **Recalling firm:** Hamilton Medical AG
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-25
- **Report date:** 2019-07-17
- **Termination date:** 2024-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bonaduz, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1874-2019

## Citation

> AI Analytics. FDA recall Z-1874-2019. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1874-2019. Source: US FDA. Licensed CC0.

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