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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90576

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 27, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Hamilton Medical AG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

HAMILTON-C6 Intensive Care Ventilator, REF: 160021

Z-1525-2022
Recall number
Z-1525-2022
Initiated
June 27, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Hamilton Medical AG
Quantity
358

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

US nationwide distribution including Puerto Rico.