Recall Z-1429-2023 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical AG
HAMILTON-C6, REF: 160021
| Date | Apr 25, 2023 (initiated Mar 14, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| 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 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 Techni |
| Quantity | 103 |
| Distribution | US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201658 | Hamilton-C6 Hamilton Medical AG, Dec 11, 2020 |