FDA-Device2025-07-16Class I
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
Given Imaging Ltd.
Hazard
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
Sold states
US Nationwide. Global Distribution.
Affected count
128,202 units
Manufactured in
New Industrial Park, POB 258, 2 Hacarmel St., Yokne'Am Ilit, N/A, Israel
Products
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2047-2025Don't want to check this manually?
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