HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to

FDA device recall Z-2140-2023 · posted 2023-07-21 · Open, Classified

Recall details

Recalling firm

Hamilton Medical, Inc.

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.

Action taken

On 06/15/2023, the firm sent via email an "URGENT Medical Device Correction" Letter to customers informing them that, affected HAMILTON-C2/C3/C1/T1 ventilators which are used for long-term ventilation in neonatal group will switch to the "Ambient State" if the ventilation time is exceeding 91 days. During the "Ambient State" the ventilator will alarm audibly and visually displayed on the screen and would result in no active ventilation being provided to patients. Instructions for Customers: Required user actions if failure occurs: In such a case, perform the following actions steps: 1. Provide alternative ventilation immediately. 2. You must switch off ventilator power to exit the Ambient State . 3. Once patient safety is ensured, it is required to have the ventilator serviced. (After passing the service software the device can be returned to use.) For further information see chapter Ambient State in the respective Operator s Manual: HAMILTON-C1/T1 SW version d2.2.X Section 7.6.2 (pg. 130) HAMILTON-C2 SW version d2.2.X section B.8 (pg. 330) HAMILTON-C3 SW version d2.0.X section 7.7.3 (pg. 123) Mandatory periodic, preventive action: To avoid this malfunction, perform the following: The device needs to be restarted regularly. Note: Switching into standby is not sufficient. It is recommend to perform the restart of the device during the regular exchange of the breathing circuits (usually every 28 days). Preventing the failure from occurring through a software update: For HAMILTON-C1/T1: Update the devices to SW version 3.0.0 or higher. -Until the malfunction is corrected as part of this Medical Device Correction, please continue to follow the instructions in this Medical Device Correction. -Clearly display this correction notice at your site. For Questions: Hamilton Medical AG Technical Support at Tel. +41 58 610 10 20 Email: techsupport@hamilton-medical.com Added 08/30/2023 - Firm notified customers in Puerto Rico on ****

Root cause

Software design

Status

Open, Classified

Product code

CBK

Quantity affected

2319 systems

Distribution

U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnes

Date initiated

2023-06-15

Date posted

2023-07-21

Location

Reno, NV

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