Reported Jun 17, 2020 · Ongoing
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Infinix-8000C with Catheterization Table
- CAT-850B or CAT-860B - Product UsageThis device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities
- Lot codes and dates
- Serial Numbers
B8B1972001A9A1592001A3A14Z2001AEB1812002A1B1552001A9C18Y2007A3E1922002B5B1952001A9C1822006A9B1622002A9B1722003A5C1622001B3B19Y2001A1D1772003B1B19X2001A5C16Y2002A9C1822005A1E1862008A1D1752002A1E1832004A1E1852005A1E1852006A5E1862003AEA17X2001
- Serial Numbers
- Amount recalled
- 24
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Canon Medical System, USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.