Hamilton Medical AG
BONADUZ Graubunden, CH
Hamilton Medical AG appears in FDA device records in BONADUZ Graubunden, CH. FDA records list 45 510(k) clearances between and , no PMA records and 5 registered establishments. As of , FDA records show 39 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Hamilton Medical AG carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- HAMILTON BONADUZ AGregistration
510(k) clearance history
FDA records hold 45 510(k) clearances for Hamilton Medical AG between 1985 and 2021. The busiest year on record is 2012, with 5. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 2 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 2 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201306 | HAMILTON-C3 | CBK | Substantially Equivalent | |
| K201658 | Hamilton-C6 | CBK | Substantially Equivalent | |
| K193228 | Hamilton-G5 | CBK | Substantially Equivalent | |
| K181216 | HAMILTON-T1, HAMILTON-C1 | CBK | Substantially Equivalent | |
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | Substantially Equivalent | |
| K161450 | HAMILTON-C3 | CBK | Substantially Equivalent | |
| K153046 | HAMILTON-MR1 | CBK | Substantially Equivalent | |
| K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | Substantially Equivalent | |
| K150893 | IntelliCuff | BSK | Substantially Equivalent | |
| K140939 | HAMILTON-T1,HAMILTON-C1 | CBK | Substantially Equivalent | |
| K122438 | HAMILTON-MR1 | CBK | Substantially Equivalent | |
| K131774 | HAMILTON-G5 | CBK | Substantially Equivalent | |
| K123637 | HAMILTON-C3 | CBK | Substantially Equivalent | |
| K121225 | HAMILTON-C2 | CBK | Substantially Equivalent | |
| K120574 | HAMILTON-C1 | CBK | Substantially Equivalent | |
| K120670 | HAMILTON-T1 | CBK | Substantially Equivalent | |
| K112006 | HAMILTON-TC1 | CBK | Substantially Equivalent | |
| K103803 | HAMILTON-G5 | CBK | Substantially Equivalent | |
| K102775 | HAMILTON-C2 | CBK | Substantially Equivalent | |
| K092148 | HAMILTON-C2 | CBK | Substantially Equivalent | |
| K090468 | HAMILTON-C2 | CBK | Substantially Equivalent | |
| K081521 | MODIFICATION TO HAMILTON-G5 | CBK | Substantially Equivalent | |
| K080181 | MODIFICATION TO GALILEO GOLD | CBK | Substantially Equivalent | |
| K070513 | HAMILTON-G5 | CBK | Substantially Equivalent | |
| K071194 | RAPHAEL COLOR ASV VENTILATOR | CBK | Substantially Equivalent | |
| K061090 | GALILEO GOLD ASV | CBK | Substantially Equivalent | |
| K052863 | RAPHAEL COLOR | CBK | Substantially Equivalent | |
| K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR | BTI | Substantially Equivalent | |
| K040574 | GALILEO GOLD | CBK | Substantially Equivalent | |
| K022679 | RAPHAEL | CBK | Substantially Equivalent | |
| K030563 | ARABELLA NCPAP MASKS | BZD | Substantially Equivalent | |
| K001686 | GALILEO VENTILATOR | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K982910 | HAMILTON MEDICAL GALILEOVENTILATOR | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K990293 | ALADDIN II MONITORING OXYGEN/AIR MONITOR | BZR | Substantially Equivalent | |
| K960359 | ALADDIN MONITORING OXYGEN/AIR MIXER | BZR | Substantially Equivalent | |
| K945740 | INFANT FLOW SYSTEM | BZO | Substantially Equivalent | |
| K901448 | VEOLAR VENTILATOR | CBK | Substantially Equivalent | |
| K900465 | MAX TRANSPORT VENTILATOR | CBK | Substantially Equivalent | |
| K894426 | LEONARDO INFORMATION SYSTEM | CBK | Substantially Equivalent | |
| K894316 | AMADEUS VENTILATOR | CBK | Substantially Equivalent | |
| K881482 | VEOLAR VENTILATOR | CBK | Substantially Equivalent | |
| K871792 | VEOLAR VENTILATOR | CBK | Substantially Equivalent | |
| K861432 | VEOLAR VENTILATOR | CBK | Substantially Equivalent | |
| K854026 | VEDLAR VENTILATOR (MODIFICATION) | Substantially Equivalent | ||
| K844809 | CONTINUOUS VENTILATOR | GBX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8030996 | 3001421318 | HAMILTON BONADUZ AG | VIA CRUSCH 8, BONADUZ Graubunden 7402 CH | 2026 | |
| 3001421318 | 3001421318 | HAMILTON MEDICAL AG | VIA CRUSCH 8, BONADUZ Graubunden 7402 CH | 2026 | |
| 3016723884 | 3016723884 | HAMILTON MEDICAL, INC. | 201 Edison Way, Reno, NV 89502 US | 2026 | |
| 3014766741 | 3014766741 | Hamilton Medical AG | Parc lndustrial Vial 10, Domat / Ems Graubunden 7013 CH | 2026 | |
| 3029906224 | 3029906224 | Hamilton Medical AG | Parc Industrial Vial 12, Domat/Ems Graubunden 7013 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- GBXCatheter, Irrigation
- JJHClinical Sample Concentrator
- BTICompressor, Air, Portable
- BSKCuff, Tracheal Tube, Inflatable
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- DQAOximeter
- BZOSet, Tubing And Support, Ventilator (W Harness)
- JQWStation, Pipetting And Diluting, For Clinical Use
- MZATest, Equipment, Automated Bloodborne Pathogen
- BYXTubing, Pressure And Accessories
- CBKVentilator, Continuous, Facility Use
- BZDVentilator, Non-Continuous (Respirator)
Recall records
Showing 25 of 39| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2463-2026 | 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 result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement | Class I | Open, Classified | |
| Z-2625-2026 | IntelliCuff, Portable automatic cuff pressure controller REF: 951001 | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user. | Class II | Open, Classified | |
| Z-2167-2025 | Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators. | 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 rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction. | Class I | Open, Classified | |
| Z-2328-2025 | Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates. | 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 enter ambient state, resulting in an interruption of ventilation. | Class I | Open, Classified | |
| Z-2020-2024 | 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 for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator. | Class I | Open, Classified | |
| Z-2530-2023 | Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation. | Class I | Open, Classified | |
| Z-2529-2023 | Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation. | Class I | Open, Classified | |
| Z-2528-2023 | Hamilton-MR1, REF: 161010, Intensive Care Ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation. | Class I | Open, Classified | |
| Z-2527-2023 | Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation. | Class I | Open, Classified | |
| Z-2526-2023 | Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation. | Class I | Open, Classified | |
| Z-2525-2023 | Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation. | Class I | Open, Classified | |
| Z-2142-2023 | HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates | Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. | Class I | Open, Classified | |
| Z-2141-2023 | HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates | Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. | Class I | Open, Classified | |
| Z-2140-2023 | HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates | Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. | Class I | Open, Classified | |
| Z-2139-2023 | HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates | Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. | Class I | Open, Classified | |
| Z-1429-2023 | 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 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. | Class II | Open, Classified | |
| Z-0267-2023 | Hamilton-C6 | Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again. | Class II | Open, Classified | |
| Z-1525-2022 | HAMILTON-C6 Intensive Care Ventilator, REF: 160021 | Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed | Class I | Open, Classified | |
| Z-1385-2022 | HAMILTON-H900 Humidifier, Models: 950001, 950004 | When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber. | Class III | Completed | |
| Z-1874-2019 | HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. | New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately. | Class I | Terminated | |
| Z-1372-2018 | Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital. | After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available. | Class II | Open, Classified | |
| Z-1371-2018 | Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital. | After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available. | Class II | Open, Classified | |
| Z-2796-2018 | Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital. | An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side. | Class II | Terminated | |
| Z-2795-2018 | Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital. | An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side. | Class II | Terminated | |
| Z-0335-2018 | Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates. | Issue related to the performance of the motor in recalled product. During use, motor may cease to function. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain