Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland HAMILTON-C6, REF: 160021 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HAMILTON-C6, REF: 160021
Brand
Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland
Lot Codes / Batch Numbers
Software Version: 1.2.1, UDI-DI: 07630002808590
Products Sold
Software Version: 1.2.1, UDI-DI: 07630002808590
Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland is recalling HAMILTON-C6, REF: 160021 due to Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.
Recommended Action
Per FDA guidance
On 3/14/23, correction notices were emailed to health care facilities and distribution partners. Customers were told the following: 1) Firm will reach out to schedule the software update. 2) See Operation's Manual, Section 7.7, Safety Ventilation. The device must turn off to exit Safety Ventilation. 3) Complete and return the confirmation form to bret.everett@hamiltonmedical.com 4) If the malfunction occurs take the following actions: a) Monitor your patient. b) Provide an alternative device for ventilation. c) Have the ventilator serviced. If you have questions or concerns, contact Technical Support at 1-800-426-6331, option #2, or email Reno.TechSupport@hamiltonmedical.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026