FDA recall Z-2339-2021

Product

OASIS MRI System

Reason for recall

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

Distribution

Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.

Key facts

Status

Terminated

Initiation date

2021-07-29

Report date

2021-09-01

Termination date

2023-09-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Twinsburg, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2339-2021