System, Imaging, Gastrointestinal, Wireless, Capsule

Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).

The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.

Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imag

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.

Miriam Capsule Endoscope System. Model MR1100

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.

CapsoCAM Plus, UDI: 00867770000209

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.

CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule

Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.

The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualizat

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 diagnosis and the patient may need to repeat the exam.