NAMIC 90400435Recalls & reported problems
Medline Industries, Inc. · CMS, SQUEEZE, 72 W/BALL PG · 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 10193489068191), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that "The team went through almost all of them in one day due to it leaking air out of the top of them. Difficult time filling the buritrol. It was making a hissing sound."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950419 ↗
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