STERIS 4085, 5085 & 5085SRT Surgical Tables
FDA Recall Z-1941-2010 · Posted 2010-06-30
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Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFQO
Date Initiated2010-05-14
Date Terminated2012-02-24
Product Quantity79 units
Reason for Recall
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
Firm Action
On May 14, 2010 the firm sent FCL letters to their customers notifying them of the problem. They informed their customers that a service representative will contact them to arrange correction of the unit.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA, Australia, India, Korea & New Zealand
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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