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 (G3-1
Laborie Medical Technologies Corp
The 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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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);
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1. Catalog Number: G3-6Model UDI-DI: Primary UDI-DI: 08717775955047Model Basic UDI-DI: 87177759500G3G8Model All serial numbersModel 2. Catalog Number: G3-7Model UDI-DI: Primary UDI-DI: 08717775955054Model 3. Catalog Number: G3-8Model UDI-DI: Primary UDI-DI: 08717775955061Model 4. Catalog Number: G3-12Model UDI-DI: Primary UDI-DI: 08717775955078Model 5. Catalog Number: G3-14Model UDI-DI: Primary UDI-DI: 08717775955085UPC 08717775955047UPC 08717775955054UPC 08717775955061UPC 08717775955078UPC 08717775955085Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.