Recall Z-2669-2026 ยท FFX System, Gastrointestinal Motility (Electrical)
Laborie Medical Technologies Corp
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);
| Date | Jul 2, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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 S |
| Quantity | 372 units |
| 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, Leban |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121014 | SOLAR GI Medical Measurement Systems B.V., Aug 1, 2012 |