FDA recall Z-1827-2020

Product

CapsoCAM Plus, UDI: 00867770000209

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-10-18

Report date

2020-05-06

Termination date

2021-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saratoga, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1827-2020