Recall Z-2020-2024— Hamilton Medical AG

Name: FDA recall Z-2020-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-15

Class I · Ongoing

Class I FDA medical device recall by Hamilton Medical AG, initiated 2024-05-15. It names one FDA 510(k) clearance: K201658. Product: Ventilator HAMILTON-C6, PN: 160021. Reason: 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..

Recalling firm: Hamilton Medical AG
Classification: Class I
Status: Ongoing
Initiated: 2024-05-15
Firm location: Bonaduz, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K201658 — Hamilton-C6Hamilton Medical AG·cleared 2020-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ventilator HAMILTON-C6, PN: 160021

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.