HAMILTON-C6, REF: 160021
FDA device recall Z-1429-2023 · posted 2023-04-25 · Open, Classified
Recall details
- Recalling firm
- Hamilton Medical AG
- 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.
- Action taken
- 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
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- CBK
- Quantity affected
- 103
- Distribution
- US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
- Date initiated
- 2023-03-14
- Date posted
- 2023-04-25
- Location
- Bonaduz, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Hamilton-C6 (K201658) | Hamilton Medical AG | 2020-12-11 |