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Terminated

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.

FDA Recall Z-0645-2019 · Posted None

Recalling FirmDeerfield Imaging, Inc.
Recall StatusTerminated
Product CodeFQO
Date Initiated2018-11-06
Date Terminated2021-07-25
Product Quantity15 units

Reason for Recall

Table may drift in the roll position while in use

Firm Action

The firm initiated the recall by letter on 11/06/2018. The letter explained the issue, requested the consignee follow the recommended daily test in all positions until the roll cylinders are exchanged.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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