FDA Device recall Z-1525-2022
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
- FDA Device
- Class I
- ongoing
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class I recall of HAMILTON-C6 Intensive Care Ventilator, REF: 160021 by Hamilton Medical Ag, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1525-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-06-27 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hamilton Medical Ag |
| Distribution | US |
Product
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
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
Identifiers
| code_info | UDI-DI: 07630002808590, Serial Numbers: 5663, 6995, 6907, 6952, 7177, 7772, 6932, 6157, 8658, 7307, 5939, 6858, 6231, 8…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1525-2022%22
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