HAMILTON-C6, REF: 160021
FDA Recall Z-1429-2023 · Posted 2023-04-25
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Recalling FirmHamilton Medical AG
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2023-03-14
Product Quantity103
Reason for Recall
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.
Firm Action
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 [email protected]
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 [email protected]
Root Cause
Software design
Distribution Pattern
US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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