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Recall Observatory FDA recall evidence

Device product

A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Z-2402-2012

February 17, 2010

Class II

Product summary

Firm
Steris Corporation
Event
Event 54705
Status
Terminated
Classification
Class II
Quantity
11,044 Units
Official record key
device-enforcement:Z-2402-2012

Official wording

Reason: Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move without prompting by an operator .

Code information: B420702032 to 0402110097

Distribution pattern: Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move without prompting by an operator .