Capso Vision recalls The CapsoCam Plus (SV-3) capsules due to incorrect capture mode causing data recording failure. This may lead to delayed diagnosis and repeat exams. Affected units have specific serial numbers and lot numbers.
Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.
Capso Vision is recalling The CapsoCam Plus (SV-3) capsules because they have a faulty capture mode that won't record data when ingested. This risk means patients might need to repeat exams and delay diagnosis.
The capsule's capture mode is incorrect, so it fails to record data during ingestion. This can cause delays in diagnosing small bowel issues and may require patients to repeat the exam.
Adults who own or use The CapsoCam Plus (SV-3) capsules for small bowel visualization. Patients who have ingested the recalled capsules are most at risk.
Check for the product name 'The CapsoCam Plus (SV-3)' with serial numbers starting with A00Y2K.700 through A0199Y.700. The lot number is 01-19-0070.
Look for the serial numbers listed in the recall notice (starting with A00Y2K.700 through A0199Y.700) to confirm if your capsule is affected.
The capsule has an incorrect capture mode that won't record data when ingested, which can delay diagnosis and require repeat exams.
Check if your capsule's serial number is in the list provided in the recall notice. If it is, you may need to repeat the exam.
The recall notice does not mention a fix or remedy; the remedy is null.
We’ve drafted a message you can send Capso to request your refund or repair — edit it as you like.
Subject: Recall Z-2536-2020 — Capso Capso Hello, I own a Capso that is covered by recall Z-2536-2020 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.
