FDAClass IIJune 17, 2020

Infinix-8000C with Catheterization Table CAT-850B or recall

Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a…

Why was Infinix-8000C with Catheterization Table CAT-850B or recalled?

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: B8B1972001, A9A1592001, A3A14Z2001, AEB1812002, A1B1552001, A9C18Y2007, A3E1922002, B5B1952001, A9C1822006, A9B1622002, A9B1722003, A5C1622001, B3B19Y2001, A1D1772003, B1B19X2001, A5C16Y2002, A9C1822005, A1E1862008, A1D1752002, A1E1832004, A1E1852005, A1E1852006, A5E1862003, AEA17X2001

Product
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a…
Recalling firm
Canon Medical System, USA, INC.
Quantity
24
Distribution
US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.
Recall date
June 17, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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