FDA recall, , Moderate risk
Solar GI System (Water Perfusion)
The Solar GI System can accumulate moisture inside its tubing or sensors, affecting airflow or pressure measurement.
Summary by Recall Canary from the FDA notice
What happened
Laborie Medical Technologies Corp, of Portsmouth, New Hampshire, is recalling the Solar GI System (Water Perfusion) because under extended clinical use conditions, 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. The company began the recall on May 21, 2026, and the FDA added it to its Enforcement Report on July 2, 2026.
The recalled products include the 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), and Solar GI HRAM H2O, 24p, Trolley system (G3-14). The recall affects 372 units distributed worldwide, including the US Nationwide and many other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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);- UDI-DI
- 08717775955047
- 08717775955054
- 08717775955061
- 08717775955078
- 08717775955085
- Lot code
- All serial numbers
Recall details
- Company began the recall
- Sold in
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.
- Company
- Laborie Medical Technologies CorpPortsmouth, New Hampshire
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98876
- Recall number
- Z-2669-2026
- Quantity recalled
- 372 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
