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Solar GI System (Water Perfusion) recallZ-2669-2026 · Laborie Medical Technologies Corp · initiated May 21, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Laborie Medical Technologies Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2669-2026
Status
Open, Classified
Initiated by the company
May 21, 2026
Posted by the FDA
Jul 2, 2026
Recalling firm
Laborie Medical Technologies Corp
Quantity
372 units
Product code
FFX
FDA submissions
K121014
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic. Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Namibia, Nepal, Netherlands. Oman, Osterreich, Pakistan, Poland, Portugal, Puerto Rico, Qatar, Russia, Russian Federation, Saudi Arabia, Serbia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, United Kingdom, and Vietnam.

Product description

Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);

Code information (models, lots, serial numbers)

1. Catalog Number: G3-6; UDI-DI: Primary UDI-DI: 08717775955047; Basic UDI-DI: 87177759500G3G8; All serial numbers; 2. Catalog Number: G3-7; UDI-DI: Primary UDI-DI: 08717775955054; Basic UDI-DI: 87177759500G3G8; All serial numbers; 3. Catalog Number: G3-8; UDI-DI: Primary UDI-DI: 08717775955061; Basic UDI-DI: 87177759500G3G8; All serial numbers; 4. Catalog Number: G3-12; UDI-DI: Primary UDI-DI: 08717775955078; Basic UDI-DI: 87177759500G3G8; All serial numbers; 5. Catalog Number: G3-14; UDI-DI: Primary UDI-DI: 08717775955085; Basic UDI-DI: 87177759500G3G8; All serial numbers;

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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