HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Hamilton Medical AG
- Reason for Recall:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1525-2022
Related Recalls
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.
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.
Hamilton Medical AG
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.
Ventilator HAMILTON-C6, PN: 160021
Hamilton Medical AG
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.