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Recall Observatory FDA recall evidence

Device 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.

Z-0645-2019

November 06, 2018

Class II

Product summary

Firm
Deerfield Imaging, Inc.
Event
Event 81574
Status
Terminated
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-0645-2019

Official wording

Reason: Table may drift in the roll position while in use

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Table may drift in the roll position while in use