Solar GI System Recall Issued by Laborie Medical Technologies
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Laborie Medical Technologies Corp is recalling 372 units of the Solar GI System (Water Perfusion) due to potential moisture accumulation affecting performance under extended use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
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What Happened Laborie Medical Technologies Corp is conducting a voluntary recall of the Solar GI System (Water Perfusion) after determining that 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, potentially affecting airflow or pressure measurement performance.
Which Products Are Affected The recall covers 372 units distributed worldwide, including 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 products include:
- Solar GI LGI H2O, 12p, Trolley system (Catalog Number: G3-6)
- Solar GI HRM H2O, 24p, Compact Pole system (Catalog Number: G3-7)
- Solar GI HRM H2O, 24p, Trolley system (Catalog Number: G3-8)
- Solar GI HRM H2O, 36p, Trolley system (Catalog Number: G3-12)
- Solar GI HRAM H2O, 24p, Trolley system (Catalog Number: G3-14) All serial numbers are affected. UDI-DI numbers are 08717775955047 (G3-6), 08717775955054 (G3-7), 08717775955061 (G3-8), 08717775955078 (G3-12), and 08717775955085 (G3-14). The recall number is Z-2669-2026 and it is classified as Class II.
What You Should Do Consumers and facilities should follow instructions provided in the firm's notification letter regarding the affected devices.
Why This Matters The recall addresses a potential performance issue with diagnostic devices used in clinical settings distributed across the United States and numerous international markets.
Source FDA Enforcement Report, recall number Z-2669-2026, Laborie Medical Technologies Corp.
Original source: FDA Official Notice ↗
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Similar body length
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Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
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