System, Gastrointestinal Motility (electrical)

EndoFLIP System that includes:

Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.

Solar GI System (Water Perfusion);

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.

Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.

ZVU Functional GI Software, REF: ZVU-3

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

Insight rev H software.

Software error may produce incorrect esophageal contraction readings.

AR ManoShield, MSS-3599, 10 pack.

The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Corrective Action (FSCA) Committee was convened. As a result of the data discussed during this meeting, a decision was made to voluntarily recall this product, and cease its further commercialization or distr

Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.