FDAFDA · Food and drugs·Recall number Z-2402-2012
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.
Published September 26, 2012 · Recall initiated: February 17, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 .
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Steris Corporation
- Distributor
- 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.
- Lot
- B420702032 to 0402110097
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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