Recall Z-2139-2023— Hamilton Medical, Inc.

Name: FDA recall Z-2139-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-15

Class I · Ongoing

Class I FDA medical device recall by Hamilton Medical, Inc., initiated 2023-06-15. It names one FDA 510(k) clearance: K181216. Product: HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Reason: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice..

Recalling firm: Hamilton Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-06-15
Firm location: Reno, NV, United States

510(k) clearances named in this recall

1 on FDA's record

K181216 — HAMILTON-T1, HAMILTON-C1Hamilton Medical AG·cleared 2019-08-02

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

HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates

Reason for recall

Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

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