Summary
The FDA issued a Class I for HAMILTON-C6 Intensive Care Ventilator, REF: 160021 by Hamilton Medical AG. Reason: Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multipl.
Details
Source
Device Recall
External ID
Z-1525-2022
Action Date
2022-08-31
Status
Ongoing
Category
device
Product Description
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Lot/Code Info: 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
Quantity Affected: 358
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
Distribution
US nationwide distribution including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-27
Company
Bonaduz
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 194 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hamilton Medical AG has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hamilton Medical AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hamilton Medical AG have FDA actions?
Hamilton Medical AG has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1525-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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