Deerfield Imaging, Inc. recalls IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Us

Recalled December 26, 2018 · FDA recall Z-0645-2019 · Deerfield Imaging

Hazard

Table may drift in the roll position while in use · FDA Class II

Units

15 units

Sold at

Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.

Description

Table may drift in the roll position while in use

Product

IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

Manufacturer(s)

Deerfield Imaging, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →