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PillCam
Given Imaging, Inc. · Model FGS-0585 · UDI-DI 07290101366263
NEZ
Prescription
10
510(k) clearances
723
Adverse events (24 deaths)
6
Recalls
16
Facilities
Description
UGI capsule, 5-pack
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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Get your free API keyRead the docsData 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.