Z-1874-2019Class I

HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed...

Name: Z-1874-2019 HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed...
Creator: Hamilton Medical AG
Published: 2019-03-25
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2019-03-25 / Terminated / root cause: software

FDA source

Hamilton Medical AG began a recall of 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... on 2019-03-25. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1874-2019
Classification: Class I
Status: Terminated
Initiated: 2019-03-25
Posted: 2019-07-11
Terminated: 2024-06-03
Recalling firm: Hamilton Medical AG
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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: software
FDA root cause: Software design
Action: On 03/25/19, the firm, Hamilton AG, issued Medical Device Field Safety Corrective Action notices to customers via certified mail with receipt response. Customers were advised that if ventilators entered the ambient state, they should provide alternate ventilation immediately. In addition, in order to exit the ambient state, you must turn off ventilator power. The firm has developed a new software version, which reduces the probability of the ventilator entering an ambient state due to the occurrence of an error which leads to the user message "panel connection lost". The firm will contact customers to schedule the software update. The firm requests that consignees distribute this notification to all end users within their organization. They also request that consignees complete and return the acknowledgement form via email: [email protected]; fax: (775) 856-5621, or mail: Hamilton Medical, Inc., PO Box 30008, Reno, NV 89520. Customers with questions are encouraged to call 1-800-426-6331, option #2. In addition, with the Medical Device Field Safety Corrective Action notices, the firm also provided customers with Medical Device Field Safety Corrective Action notices, dated 02/11/19, sent to OUS customers for Hamilton-G5 and Hamilton-S1 ventilators. Customers were advised that the Swiss firm has developed a new software for the HAMILTON-G5/S1 ventilators. The software version 2.80 reduces the probability of the ventilator entering an ambient state due to the occurrence of an error which leads to the user message "panel connection lost". When the HAMILTON-G5/S1 ventilator enters an ambient state, the following conditions apply: - The HAMILTON-G5/S1 releases both a visual and an acoustical high-priority alarm to alert medical staff. - The inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. - Provide alternative ventilation immediately. - You must turn off ventilator power to exit the Am
Quantity in commerce: 4338 units
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.
Product codes and lots: Serial numbers 16192 and lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1874-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1874-2019	Class I	Terminated	Voluntary: Firm initiated	2019-07-17	2019-07-11

Product code CBK

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)