FDAClass IIAugust 19, 2015

Oasis Coil Extension Cable used with Hitachi Oasis MRI recall

Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the…

Why was Oasis Coil Extension Cable used with Hitachi Oasis MRI recalled?

The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.

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 #'s: M001to M108, M110 to M175, M951 & M952.

Product
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the…
Recalling firm
Hitachi Medical Systems America Inc
Quantity
173 units
Distribution
US Nationwide in the states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WY and the country of Mexico.
Recall date
August 19, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls