Class 1 Device Recall Hamilton G5 Ventilator

• Date Initiated by Firm: March 25, 2019
• Date Posted: July 11, 2019
• Recall Status: Terminated on June 03, 2024
• Recall Number: Z-1874-2019
• Recall Event ID: 82328
• 510(K)Number: K081521 K103803 K131774
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• 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.
• Code Information: Serial numbers 16192 and lower
• FEI Number: 3001421318
• Recalling Firm/ Manufacturer: Hamilton Medical AG; Via Crusch 8; Bonaduz Switzerland
• Manufacturer 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.
• FDA Determined 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: nicole.robinson@hamiltonmedical.net; 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.
• Total Product Life Cycle: TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK