Capso Vision recalls specific CapsoCAM Plus capsule endoscopy systems with serial numbers starting with A017NP.699. A defect in the capsule window may crack when ingested, risking fluid leakage and data loss. Patients may need to repeat the exam.
Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.
Capso Vision is recalling specific models of their CapsoCAM Plus capsule endoscopy systems. A defect in the capsule window could crack when ingested, leading to fluid leakage inside the capsule and potential data loss. This might require patients to repeat the exam.
The capsule window may crack during production or packaging, which could allow fluid from the patient to leak into the capsule. This might damage internal components and prevent proper data retrieval, requiring the patient to repeat the exam.
Patients who have the recalled CapsoCAM Plus capsule endoscopy systems with the listed serial numbers (starting with A017NP.699) are affected. The risk is low as the defect is unlikely to cause serious injury during normal use.
Check if your CapsoCAM Plus system has a serial number starting with A017NP.699 (e.g., A017NP.699, A0168D.699, etc.). The recall covers specific serial numbers listed in the official notice.
Look for serial numbers starting with A017NP.699 on your CapsoCAM Plus system.
If you have a recalled unit, contact Capso Vision directly for instructions on returning or replacing the device.
The capsule window may crack during production or packaging, which could allow fluid to leak into the capsule and damage internal components.
Yes, if the capsule cracks, you may need to repeat the exam as the patient data may not be retrieved.
Check if your serial number starts with A017NP.699 (e.g., A017NP.699, A0168D.699, etc.).
We’ve drafted a message you can send Capso to request your refund or repair — edit it as you like.
Subject: Recall Z-1827-2020 — Capso Capso Hello, I own a Capso that is covered by recall Z-1827-2020 from Capso. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
