Terminated

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.

FDA Recall Z-1874-2019 · Posted 2019-07-11

Recalling FirmHamilton Medical AG

Recall StatusTerminated

Product CodeCBK

Date Initiated2019-03-25

Date Terminated2024-06-03

Product Quantity4338 units

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.

Firm 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

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131774HAMILTON-G5Hamilton Medical AG · 2013-10-09 K103803HAMILTON-G5Hamilton Medical AG · 2011-11-23 K081521MODIFICATION TO HAMILTON-G5Hamilton Medical AG · 2008-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.