Deerfield Imaging, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0646-2019)

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 ORT 100 table, Part Numbers: (a) 110470-000, (b) 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-0646-2019

Event ID: 81574

Reason for Recall:

Table may drift in the roll position while in use

Status: Terminated

Product Quantity: 27 units

Code Information:

(a) 110470-000, Serial Numbers: 10002845, 10002341, 10003629, 10003801, 10003830, 10002847, 10002796, 10003243, 10002654, 10003841, 10002607, 10007348, 10007424, 10005651, 10004250, 10004439, 10003241, 10006886, 10002848, 10006438, 10003007, 10004576, 10003245 (b) 110470-600, Serial Numbers: 10003244, 10003064, 10003244, 10002343

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated