Recall Z-2669-2026

Reason for recall

Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.

FDA-determined cause: Device Design

Action taken

Laborie Medical Technologies notified consignees on about 05/21/2026 via letter. Consignees were instructed to always use the pre-check instructions provided in the IFU to ensure that the device is operating properly, ensure all operators are aware of the outlined IFU updates in the customer notification to include the following: 1. Updated 3-Minute Blow-Out Moisture Removal Maintenance Procedure (New IFU Section 3.0 and provided in the attached insert). 2. Laborie has added the following to the revised IFU in addition to the blow-out procedure presented in Attachment 1: " A Device Use Life Statement in Section 1.8. " The statement in Section 2.4.3. Consignees were also instructed to review the Enclosed IFU Insert Section 3.0 for the updated Blow-Out Moisture Removal Maintenance Procedure and ensure all clinical users are trained to the new maintenance procedure. Laborie recommends that customers print-out the Blow-Out procedure and post it on or near the device for awareness of the change in the Blow-Out Cycle. Distribute this notification and IFU insert to all clinical operators, supervisors and trainers, biomedical engineering / technical support staff, and any personnel responsible for system cleaning, setup, or maintenance.