Home › Device types › NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
FDA product code NEZ · Class 2 · Gastroenterology, Urology
163
Registered devices
723
Adverse events
6
Recalls
47
510(k) clearances
Devices with this code
ANTENNA UNIT — OLYMPUS MEDICAL SYSTEMS CORP.PillCam — Given Imaging, Inc.RAPID — Given Imaging, Inc.Pillcam — Given Imaging, Inc.ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENT — OLYMPUS MEDICAL SYSTEMS CORP.RAPID — Given Imaging, Inc.PillCam — Given Imaging, Inc.NaviCam ESView 3.X — ANX ROBOTICA CORPRECORDER UNIT — OLYMPUS MEDICAL SYSTEMS CORP.Pillcam — Given Imaging, Inc.PillCam — Given Imaging, Inc.CapsoCam Plus — CAPSOVISION, INC.NaviCam Small Bowel Capsule Endoscopy System — ANKON Technologies Co.,Ltd.Pillcam — Given Imaging, Inc.PillCam — Given Imaging, Inc.Pillcam — Covidien LPPillCam — Given Imaging, Inc.CapsoCam Plus — CAPSOVISION, INC.MiroCam Capusle Endoscope System — IntroMedic Co., LTD.CRADLE — OLYMPUS MEDICAL SYSTEMS CORP.NA — Given Imaging, Inc.Pillcam — Given Imaging, Inc.NaviCam XS Capsule — ANX ROBOTICA CORPPillCam — Given Imaging, Inc.
Recent 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 |
| 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 |
| 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 volta |
| 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 printe |
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