Z-1429-2023Class II

Hamilton-C6, Ref: 160021

Name: Z-1429-2023 Hamilton-C6, Ref: 160021
Creator: Hamilton Medical AG
Published: 2023-03-14
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2023-03-14 / Open, Classified / root cause: software

FDA source

Hamilton Medical AG began a recall of HAMILTON-C6, REF: 160021 on 2023-03-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1429-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-14
Posted: 2023-04-25
Recalling firm: Hamilton Medical AG
Product: Hamilton-C6, Ref: 160021
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: software
FDA 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 [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]
Quantity in commerce: 103
Distribution: US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
Product codes and lots: Software Version: 1.2.1, UDI-DI: 07630002808590

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1429-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1429-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25

Product code CBK

K201658Class IIHamilton-C6Hamilton Medical AG / cleared 2020-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)