BF097

• FDA 510(k) K090136 decided 20 Mar 2009 Active
• FDA GUDID UDI-DI 00724995191016 listed 23 Apr 2021 Listed

• • Terminated Z-0196-2015 FDA Class II ·initiated 10 Oct 2014 ·on shared 510(k) K090136

  The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table.

• • Terminated Z-2426-2012 FDA Class II ·initiated 6 Apr 2012 ·on shared 510(k) K090136

  STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicate that the table floor locks are unlock

• • Terminated Z-0279-2012 FDA Unclassified (pre-2012) ·initiated 17 Oct 2011

  Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.

• • Terminated Z-1941-2010 FDA Unclassified (pre-2012) ·initiated 14 May 2010

  STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 20 Mar 2009 Cleared FDA 510(k) K090136
2. 14 May 2010 Recall initiated FDA recalls Z-1941-2010
3. 17 Oct 2011 Recall initiated FDA recalls Z-0279-2012
4. 6 Apr 2012 Recall initiated FDA recalls Z-2426-2012
5. 10 Oct 2014 Recall initiated FDA recalls Z-0196-2015
6. 23 Apr 2021 Listed FDA GUDID 00724995191016

Generic name

Universal operating table, electromechanical

Model / Ref / Catalog

BF097

Primary DI / UDI-DI

00724995191016

510(k) Number

K090136 ↗

FDA product code

FQO

GMDN term

Universal operating table, electromechanical

Device class

Class I

Regulation number

878.4960

GUDID distribution status

In Commercial Distribution

Category: Universal operating table, electromechanical

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