FDA Medical Device Recalls (openFDA)
Hamilton Medical AG: HAMILTON-C6, REF: 160021
- Recall number
- Z-1429-2023
- Recalling firm
- Hamilton Medical AG
- Product
- HAMILTON-C6, REF: 160021
- Status
- Open, Classified
- Initiated
- 2023-03-14
- Posted
- 2023-04-25
- Terminated
- not on file
- 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 Technical Support at 1-800-426-6331, option #2, or email Reno.TechSupport@hamiltonmedical.com
- 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.
- Lot, serial or model codes
- Software Version: 1.2.1, UDI-DI: 07630002808590
- 510(k) numbers
- ["K201658"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3001421318
- Firm city
- Bonaduz
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28