FDA-Device2020-05-06Class II
CapsoCAM Plus, UDI: 00867770000209
Capso Vision, Inc.
Hazard
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.
Sold states
U.S.: CA, TX, FL, VA, PA, SC, HI, DC, NJ, UT, LA. Foreign: FR, AR, IT, UK, BE, TC, AU, CO, GM, GR, SP, SI, HR, MO, SW, EZ.
Affected count
1882
Manufactured in
18805 Cox Ave Ste 250, N/A, Saratoga, CA, United States
Products
CapsoCAM Plus, UDI: 00867770000209
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1827-2020Don't want to check this manually?
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