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Recall Observatory FDA recall evidence

Device product

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Z-2584-2021

August 25, 2021

Class II

Product summary

Firm
Deerfield Imaging, Inc.
Event
Event 88661
Status
Terminated
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-2584-2021

Official wording

Reason: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

Code information: UDI: 00857534006738 and 00857534006349 Model Number: 113821-000 (Serial Number: 10002220); Model Number: 113821-600 (Serial Numbers: 10002692, 10006152, 10006991, 10004513, 10006997, and 10003754); Model Number: 114148-000 (Serial Numbers: 10004463, 10006891, 10005189, 10005190, 10004327, and 10004997)

Distribution pattern: Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.