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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-2585-2021

August 25, 2021

Class II

Product summary

Firm
Deerfield Imaging, Inc.
Event
Event 88661
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-2585-2021

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: 00857534006356 Model Number: 114093-000; Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255.

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.