IntraMarX Radiopaque Markers
ANX ROBOTICA CORP · Model AGIROMC1-1(DD) · UDI-DI 00850015518010
Description
The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Laborie Medical Technologies Corp | 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 h |
| 2026-05-13 | Covidien, LLC | Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures. |
| 2025-06-04 | Diversatek Healthcare | 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 |
| 2023-07-25 | Diversatek Healthcare | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. |
| 2011-10-12 | Sierra Scientific Instruments Inc | 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 Fi |
| 2009-02-23 | Sandhill Scientific, Inc | Software error may produce incorrect esophageal contraction readings. |
| 2004-04-28 | Medtronic Gastroenterology / Urology | Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short. |
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