FDA Medical Device Recalls (openFDA)
Hamilton Medical AG: HAMILTON-C6 Intensive Care Ventilator, REF: 160021
- Recall number
- Z-1525-2022
- Recalling firm
- Hamilton Medical AG
- Product
- HAMILTON-C6 Intensive Care Ventilator, REF: 160021
- Status
- Open, Classified
- Initiated
- 2022-06-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- Root cause
- Device Design
- Action
- On 6/27/22 Field Safety Notices were emailed to health care facilities, distributors, and service engineers who were informed to take the following actions: 1) In case of a loose status indicator board observed by the user, the front housing containing the status indicator board shall be replaced. This replacement prevents the water ingress that may lead to ambient state. 2) Check your affected ventilator and inform the distributor immediately if you detect the loosening of the status indicator board. 3) Your local distributor or service engineer will contact you shortly. 4) Loose status indicator board may not lead immediately to an ambient state, however it shall be replaced immediately to avoid any risk to the patient. 5) According to the Operator s manual, make sure to always have an alternative means of ventilation available when using ventilation devices. 6) Complete and return the confirmation sheet. Customers with questions can contact the firm: +41 58 610 10 20, techsupport@hamilton-medical.com
- Quantity
- 358
- Distribution
- US nationwide distribution including Puerto Rico.
- Lot, serial or model codes
- UDI-DI: 07630002808590, Serial Numbers: 5663, 6995, 6907, 6952, 7177, 7772, 6932, 6157, 8658, 7307, 5939, 6858, 6231, 8620, 6349, 8356, 6480, 8322, 8306, 9100, 9101, 9099, 9098, 6219, 7894, 7861, 8003, 6723, 7802, 4833, 7265, 7980, 7666, 7382, 6774, 7358, 7719, 6896, 6925, 9073, 9062, 9298, 9294, 9301, 9292, 9293, 9290, 9300, 9299, 9291, 9231, 9132, 9108, 8310, 8604, 8255, 8599, 7156, 8313, 8344, 8590, 8087, 8348, 8490, 8151, 7174, 8594, 8477, 8122, 8063, 9353, 9230, 9329, 9243, 9235, 9236, 9337, 9228, 9224, 9229, 9225, 9103, 8413, 6149, 8178, 8401, 7827, 8406, 8409, 7826, 6416, 7831, 6280, 9128, 9260, 9257, 9125, 9120, 9259, 9258, 9354, 8325, 8297, 7777, 6212, 6516, 6871, 8099, 6562, 8258, 5679, 5681, 7808, 7115, 8601, 7349, 7130, 6658, 7581, 7819, 8346, 6537, 8235, 7410, 6868, 8049, 8281, 7966, 7787, 9241, 9242, 9054, 9075, 9131, 9121, 9137, 9134, 9133, 9118, 6350, 7122, 7117, 6790, 7614, 8121, 7884, 8102, 8720, 8715, 8726, 8718, 8719, 9248, 9244, 9127, 9138, 9126, 8256, 8371, 9107, 9109, 9036, 9110, 9069, 9063, 9067, 8097, 9129, 9130, 9459, 8723, 8722, 8713, 8702, 8725, 8714, 8727, 8706, 8517, 8717, 7822, 8148, 7695, 8261, 7165, 6944, 7420, 6937, 7150, 6953, 7201, 6965, 7004, 7196, 8849, 8597, 8850, 9106, 9192, 9239, 9237, 9233, 8311, 7898, 7893, 6641, 6505, 6075, 7986, 8005, 7888, 7887, 9535, 9579, 9508, 9576, 9553, 9577, 9578, 9545, 9582, 9590, 9575, 7845, 7740, 8082, 8070, 6671, 7608, 6566, 8535, 8616, 7821, 6579, 7586, 7994, 7066, 7138, 9102, 9105, 14784, 8603, 8846, 8844, 8847, 8845, 8115, 7113, 7809, 7938, 7993, 7252, 8568, 7754, 7033, 8052, 6829, 8249, 9077, 9080, 9076, 9051, 9064, 9081, 9050, 9071, 9091, 7836, 7656, 9124, 9462, 9297, 9325, 9303, 8866, 9348, 9352, 9324, 9227, 6093, 6159, 6274, 6276, 6309, 6320, 6327, 6464, 6512, 6545, 6674, 6789, 7136, 7173, 7191, 7273, 7279, 7422, 7432, 7569, 7572, 7587, 7644, 7676, 7782, 7783, 7784, 7786, 7788, 7789, 7790, 7792, 7793, 7794, 7795, 7796, 7797, 7798, 7799, 7801, 7806, 7807, 7812, 7813, 7837, 7901, 7923, 7969, 8182, 8343, 8394, 8395, 8399, 8420, 8421, 8422, 8423, 8424, 8497, 8519, 8593, 8661, 8668, 8670, 8673, 8675, 8676, 8678, 8707, 8709, 8712, 9028, 9029, 9032, 9033, 9042, 9043, 9044, 9046
- 510(k) numbers
- ["K201658"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3001421318
- Firm city
- Bonaduz
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28