Z-2669-2026Class II

Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system...

Name: Z-2669-2026 Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system...
Creator: Laborie Medical Technologies Corp
Published: 2026-05-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2026-05-21 / Open, Classified / root cause: design

FDA source

Laborie Medical Technologies Corp began a recall of 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... on 2026-05-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2669-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-21
Posted: 2026-07-02
Recalling firm: Abbott Medical
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);
Product code: FFX System, Gastrointestinal Motility (Electrical)
Reason for recall: 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 tag: design
FDA 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 Statement in Section 1.8. " The statement in Section 2.4.3. Consignees were also instructed to review the Enclosed IFU Insert Section 3.0 for the updated Blow-Out Moisture Removal Maintenance Procedure and ensure all clinical users are trained to the new maintenance procedure. Laborie recommends that customers print-out the Blow-Out procedure and post it on or near the device for awareness of the change in the Blow-Out Cycle. Distribute this notification and IFU insert to all clinical operators, supervisors and trainers, biomedical engineering / technical support staff, and any personnel responsible for system cleaning, setup, or maintenance.
Quantity in commerce: 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, 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.
Product codes and lots: 1. Catalog Number: G3-6; UDI-DI: Primary UDI-DI: 08717775955047; Basic UDI-DI: 87177759500G3G8; All serial numbers; 2. Catalog Number: G3-7; UDI-DI: Primary UDI-DI: 08717775955054; Basic UDI-DI: 87177759500G3G8; All serial numbers; 3. Catalog Number: G3-8; UDI-DI: Primary UDI-DI: 08717775955061; Basic UDI-DI: 87177759500G3G8; All serial numbers; 4. Catalog Number: G3-12; UDI-DI: Primary UDI-DI: 08717775955078; Basic UDI-DI: 87177759500G3G8; All serial numbers; 5. Catalog Number: G3-14; UDI-DI: Primary UDI-DI: 08717775955085; Basic UDI-DI: 87177759500G3G8; All serial numbers;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2669-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2669-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02

Product code FFX

K121014Class IISolar GiMedical Measurement Systems B.V. / cleared 2012-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)