Hamilton Medical AG recalls Ventilator HAMILTON-C6, PN: 160021
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube…
Read the official notice →- Date
- 2024-06-26
- Country
- United States
- Brand
- Hamilton Medical
- Product
- Ventilator HAMILTON-C6, PN: 160021
- Classification
- Class I
- Units
- US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Hamilton Medical recalls
- 2026-07-08
USHamilton Medical AG recalls Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may…
FDA · DeviceHamilton Medical AGUS Nationwide distribution including in the states of KS, WA, VT, TX, WI, AR,…Official notice →- 2025-08-27
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Hamilton Medical AG recalls Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive…
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device…
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Hamilton Medical AG recalls Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and…
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC,…Official notice → - 2023-09-27
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Hamilton Medical, Inc. recalls Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
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FDA · DeviceHamilton Medical, Inc.Distribution US nationwide, including Puerto Rico. OUS: Not providedOfficial notice → - 2023-08-02
- US
Hamilton Medical, Inc. recalls HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally…
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
FDA · DeviceHamilton Medical, Inc.U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware…Official notice → - 2023-05-03
- US
Hamilton Medical AG recalls HAMILTON-C6, REF: 160021
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…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA,…Official notice →
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