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Recall Observatory FDA recall evidence

Device product

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.

Z-0646-2019

November 06, 2018

Class II

Product summary

Firm
Deerfield Imaging, Inc.
Event
Event 81574
Status
Terminated
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-0646-2019

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Table may drift in the roll position while in use