NAMIC 90400039Recalls & reported problems
Navilyst Medical, Inc. · CONTRAST CONTROLLER · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965904000390), received between Jul 18, 2017 and Jul 18, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), DURING AN INCOMING PRODUCT INSPECTION AT THE DISTRIBUTOR'S WAREHOUSE, LOOSE FOREIGN MATTER WAS NOTED WITHIN THE FLUID PATH OF A FLUID DELIVERY SET . THE DEVICE WAS NOT USED, WAS NOT PROVIDED TO A HOSPITAL, AND IS BEING RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6722051 ↗
Other System, x-ray, angiographic devices
- ARTIS icono ceiling 11328100Siemens Healthcare GmbH · System, x-ray, angiographic9 recalls1 report
- Artis Q ceiling 10848281Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls1 death49 reports
- Artis Q floor 10848280Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls18 reports
- Artis zee biplane 10094141Siemens Healthcare GmbH · System, x-ray, angiographic3 recalls63 reports
- Artis Q.zen ceiling 10848354Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls10 reports
- Artis Q.zen floor 10848353Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls5 reports
- Artis zee floor MN 10094142Siemens Healthcare GmbH · System, x-ray, angiographic2 recalls0 reports
- iMRX System iMRX System AR-DR MR30RSIMRIS Imaging, Inc. · System, X-Ray, Angiographic1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page