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NaviCam Locator

ANX ROBOTICA CORP · Model SB-US-2006 · UDI-DI 00810164590145

NEZ Prescription

510(k) clearances

731

Adverse events (24 deaths)

Recalls

Facilities

Description

The NaviCam Locator is used to activate the NaviCam SB capsules and may also be used to determine if the capsule is still within the body.

Recalls

Date	Firm	Reason
2020-02-26	Capso Vision, Inc.	Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of di
2019-10-18	Capso Vision, Inc.	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 capsu
2019-07-03	Capso Vision, Inc.	Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
2017-02-15	IntroMedic Co., Ltd.	When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.
2011-03-08	Given Imaging Ltd.	The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.
2007-12-13	Given Imaging Inc	The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), were printed incorrectly.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.