HAMILTON-C2
2 catalogue numbers from 160001, listed by Hamilton Medical AG, Switzerland, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
2catalogue numbers in this listing
35510(k) clearances naming this product code
31recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Hamilton Medical AG, Switzerland |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-21 |
| Record revised | 2022-01-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-08-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 160001 | Withdrawn | |
| 160002 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201306 | 2021-02-05 |
| K201658 | 2020-12-11 |
| K193228 | 2020-05-04 |
| K181216 | 2019-08-02 |
| K161450 | 2017-04-27 |
| K153046 | 2016-09-06 |
| K140939 | 2015-09-02 |
| K122438 | 2013-11-20 |
| K131774 | 2013-10-09 |
| K123637 | 2012-12-21 |
| K121225 | 2012-11-16 |
| K120574 | 2012-05-30 |
| K120670 | 2012-04-03 |
| K112006 | 2012-02-09 |
| K103803 | 2011-11-23 |
| K102775 | 2011-01-21 |
| K092148 | 2010-03-04 |
| K090468 | 2009-06-15 |
| K081521 | 2008-09-25 |
| K080181 | 2008-06-24 |
| K070513 | 2007-11-26 |
| K071194 | 2007-10-18 |
| K061090 | 2006-07-17 |
| K052863 | 2006-01-06 |
| K040574 | 2004-10-27 |
| K022679 | 2003-10-22 |
| K001686 | 2000-06-23 |
| K982910 | 1999-09-14 |
| K901448 | 1991-12-20 |
| K900465 | 1990-06-18 |
| K894426 | 1989-09-26 |
| K894316 | 1989-09-22 |
| K881482 | 1988-06-16 |
| K871792 | 1988-04-21 |
| K861432 | 1986-05-06 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Hamilton Medical AG | UDI-DI | 2023-06-15 | Class I | Software design | Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. | 399 systems |
Recalls
15 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-06-03 | Class I | Equipment maintenance | 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, resu | 1040 systems | |
| 2024-05-15 | Class I | Packaging change control | 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, | 68 | |
| 2023-07-26 | Class I | Nonconforming Material/Component | 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. | 76 units | |
| 2023-07-26 | Class I | Nonconforming Material/Component | 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. | 1216 units | |
| 2023-07-26 | Class I | Nonconforming Material/Component | 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. | 164 units | |
| 2023-07-26 | Class I | Nonconforming Material/Component | 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. | 12 units | |
| 2023-07-26 | Class I | Nonconforming Material/Component | 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. | 6 units | |
| 2023-07-26 | Class I | Nonconforming Material/Component | 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. | 4 shielding set | |
| 2023-06-15 | Class I | Software design | Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. | 689 systems | |
| 2023-06-15 | Class I | Software design | Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. | 701 systems | |
| 2023-06-15 | Class I | Software design | Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. | 2319 systems | |
| 2023-03-14 | Class II | Software design | 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, A | 103 | |
| 2022-09-22 | Class II | Under Investigation by firm | 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. | 8,229 total systems worldwide (U.S. 443 systems) | |
| 2022-06-27 | Class I | Device Design | 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 r | 358 | |
| 2019-03-25 | Class I | Software design | 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 | 4338 units | 2024-06-03 |
| 2018-03-12 | Class II | Other | After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available. | 739 units total | |
| 2018-03-12 | Class II | Other | After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available. | 739 units total | |
| 2018-03-09 | Class II | Nonconforming Material/Component | 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 ala | 16 devices | 2019-03-18 |
| 2018-03-09 | Class II | Nonconforming Material/Component | 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 ala | 2 devices | 2019-03-18 |
| 2016-09-26 | Class II | Device Design | Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation. | 44 units | 2017-03-08 |
| 2016-03-09 | Class II | Software design | After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected. | 1115 | 2017-06-29 |
| 2015-03-24 | Class II | Device Design | Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device. | 248 | 2015-12-23 |
| 2014-04-22 | Class I | Device Design | Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and a | 1128 | 2017-08-24 |
| 2013-09-26 | Class II | Device Design | Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded. | 316 devices distributed in the US. | 2018-03-29 |
| 2012-12-19 | Class I | Software design | Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower mu | 97 total ventilators; 69 of part number 161005 and 28 of par | 2014-04-22 |
| 2012-02-06 | Not classified | Software design | Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions. | 456 devices in US. | 2013-10-23 |
| 2011-02-16 | Not classified | Software design | The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator. | 97 units | 2012-03-21 |
| 2006-05-24 | Not classified | Other | ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system. | 2,385 for all models | 2006-12-21 |
| 2006-05-24 | Not classified | Other | ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system. | 2,385 for all models | 2006-12-21 |
| 2006-05-24 | Not classified | Other | ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system. | 2,385 for all models | 2006-12-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.