Laborie Medical Technologies Corp: System, Gastrointestinal Motility (electrical)
Recall Summary Laborie Medical Technologies is recalling several models of the Solar GI System, which is used to measure gastrointestinal muscle function. During extended use, moisture can build up inside the system's tubing and filters, potentially affecting how accurately the device measures airflow and pressure. The recall affects devices distributed nationwide in the US and in numerous countries worldwide.
- Recalling firm
- Laborie Medical Technologies Corp
- Product
- 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);
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/5e016d97-f3ac-4e9d-9b81-65859e5687a1