| Class 2 Device Recall HAMILTONC6 Intensive Care |  |
Date Initiated by Firm | March 14, 2023 |
Date Posted | April 25, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1429-2023 |
Recall Event ID |
91925 |
510(K)Number | K201658 |
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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Product | HAMILTON-C6, REF: 160021 |
Code Information |
Software Version: 1.2.1, UDI-DI: 07630002808590 |
Recalling Firm/ Manufacturer |
Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland
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For Additional Information Contact | 41816606010 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = CBK
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