Agency classClass IIOur severity:High FDA (Devices)·Z-2402-2012·Announced 2012-09-26

Steris Surgical Table Recalled for Potential Unintended Movement

Steris Corporation is recalling 11,044 surgical tables because prohibited storage of objects on the base or column can damage the override switch, potentially causing the table to move without operator prompting.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (surgical table) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Steris Corporation is recalling 11,044 units of its mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical tables. The recall is due to a risk that the table could move without prompting by an operator. This hazard arises from a prohibited practice where customers store objects on the base and/or around the column of the table, which can damage the override switch assembly located at the top of the column cover.

The affected units were distributed worldwide, including the United States (nationwide, District of Columbia, and Puerto Rico) and numerous international locations such as Canada, the United Kingdom, Germany, and Australia. The recall covers serial numbers ranging from B420702032 to 0402110097.

Customers should immediately stop storing objects on the base or around the column of the surgical table to prevent further damage to the electronics. They should contact Steris Corporation for instructions on how to proceed with the recall and to ensure the safety of the equipment.

The recalled product

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…
Manufacturer: Steris Corporation
Category: Medical Device — Surgical Table
Hazard: unintended-movement
equipment-malfunction
Affected units: 11,044

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

B420702032 to 0402110097

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Steris Corporation

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Same hazard · unintended movement