Hamilton-C6, Ref: 160021 recallZ-1429-2023 · Hamilton Medical AG · initiated Mar 14, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hamilton Medical AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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]
Recall details
- Recall number
- Z-1429-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 14, 2023
- Posted by the FDA
- Apr 25, 2023
- Recalling firm
- Hamilton Medical AG
- Quantity
- 103
- Product code
- CBK
- FDA submissions
- K201658
- Distribution
- US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
Product description
HAMILTON-C6, REF: 160021
Code information (models, lots, serial numbers)
Software Version: 1.2.1, UDI-DI: 07630002808590
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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