Capso recalls specific models of wireless gastrointestinal capsule systems due to possible mislabeling with incorrect serial numbers, which could lead to patient misdiagnosis. Affected units have unique serial numbers starting with A00ZD4.699.
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Capso is recalling certain wireless gastrointestinal capsule systems because they might have incorrect serial numbers, which could lead to misdiagnosis of a patient's condition. This is a labeling issue that affects the accuracy of medical imaging results.
The system may have incorrect serial number labels that could cause the device to be misidentified during medical imaging. This might lead to a patient receiving the wrong diagnosis or treatment based on the incorrect labeling.
Adults who have purchased the CapsoCam Plus system for small bowel visualization may be affected. Patients undergoing gastrointestinal imaging using these specific models are at risk of misdiagnosis.
Check for serial numbers starting with A00ZD4.699, A00ZJ2.699, A00ZK2.699, or other patterns listed in the recall notice. The product was sold with specific lot numbers and serial codes.
Look for serial numbers starting with A00ZD4.699, A00ZJ2.699, A00ZK2.699, or other listed patterns in the recall notice.
The CapsoCam Plus system with serial numbers starting with A00ZD4.699, A00ZJ2.699, A00ZK2.699, and other listed patterns.
Check the serial number on your device; affected units have specific patterns like A00ZD4.699, A00ZJ2.699, A00ZK2.699, or other codes listed in the recall notice.
No action is needed if your device does not have the affected serial numbers listed in the recall notice.
We’ve drafted a message you can send Capso to request your refund or repair — edit it as you like.
Subject: Recall Z-2073-2020 — Capso Capso Hello, I own a Capso that is covered by recall Z-2073-2020 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.
