Recall Z-1827-2020— Capso Vision, Inc.
Class II · Terminated
Class II FDA medical device recall by Capso Vision, Inc., initiated 2019-10-18, terminated 2021-01-08. It names one FDA 510(k) clearance: K183192. Product: CapsoCAM Plus, UDI: 00867770000209. Reason: 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..
- Recalling firm
- Capso Vision, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-18
- Terminated
- 2021-01-08
- Firm location
- Saratoga, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.