FDA-Device2026-07-08Class IIPROCESSING DEFECT

Laborie Solar GI System water perfusion devices recalled for moisture accumulation affecting airflow and pressure measurement

OTHERNationwide distributionMedical devices

What this means

Laborie Medical Technologies' Solar GI System water perfusion devices may accumulate moisture inside tubing, filters, and pressure sensors during extended clinical use. This moisture buildup can affect how the system measures airflow and pressure, potentially impacting test results.

If you operate or maintain one of these systems, contact Laborie Medical Technologies for guidance on moisture removal procedures
Do not use the system for extended studies until you receive instructions on proper maintenance

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

372 units

Manufactured in

180 International Dr, N/A, Portsmouth, NH, United States

Products

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);

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2669-2026

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