Deerfield Imaging, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0645-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 6, 2018

Date Posted: December 26, 2018

Recall Number: Z-0645-2019

Event ID: 81574

Reason for Recall:

Table may drift in the roll position while in use

Status: Terminated

Product Quantity: 15 units

Code Information:

(a)108000-000, Serial Numbers: 10000983, 10000652 (b)108000-600, Serial Numbers: 06-0025, 10001306 (c)109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d)109682-600, Serial Numbers: 10001119, 10001188, 10003634, 05-002, 10003638, 10003623, 10001305 (e)110470-600, Serial Numbers: 10006887

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated