FDAClass IIMarch 14, 2018

INFX-8000F Fluoroscopic X-Ray Systems recall

INFX-8000F Fluoroscopic X-Ray Systems

Why was INFX-8000F Fluoroscopic X-Ray Systems recalled?

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

What should I do if I have this product?

Review the official FDA enforcement record for current 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: AHA1592004, AGB1482001, AHA1482001, AGA1492002, AHA14Z2002, AGA1552003, UUB13Y2039, AHA15Y2005, AHA1612006, AHB1662007, AGB1682004, AGB1692005, AGB16Z2006, AHB1712008, AHB1712009, AGB1712007, AHA1582003

Product
INFX-8000F Fluoroscopic X-Ray Systems
Recalling firm
Toshiba American Medical Systems Inc
Quantity
17 units
Distribution
United States
Recall date
March 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls