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Capso Vision, Inc. recalls CapsoCAM Plus, UDI: 00867770000209
Recalled May 6, 2020 · FDA recall Z-1827-2020 · Capso Vision
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. · FDA Class II
Units
1882
Sold at
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.
Description
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.
Product
CapsoCAM Plus, UDI: 00867770000209
Manufacturer(s)
Capso Vision, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →