510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1941-2010

STERIS 4085, 5085 & 5085SRT Surgical Tables

STERIS Corporation / initiated 2010-05-14 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Steris Corporation began a recall of STERIS 4085, 5085 & 5085SRT Surgical Tables on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1941-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STERIS Corporation
Product
STERIS 4085, 5085 & 5085SRT Surgical Tables
Product code
FQO Table, Operating-Room, Ac-Powered
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
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
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.
Quantity in commerce
79 units
Distribution
Worldwide distribution: USA, Australia, India, Korea & New Zealand
Product codes and lots
Model #: 4085, 5085 & 5085SRT Serial Numbers: 0400710041, 0400710042, 0400710043, 0400710044, 0401510077, 0401510080, 0401510081, 0401510082, 0401510086, 0401510087, 0401510088, 0401510089, 0401510090, 0401510092, 0401910133, 0402010001, 0402010002, 0402010003, 0403210095, 0403210096, 0403210096, 0403210097, 0403210098, 0403610046, 0403610047, 0403610048, 0403610049, 0403610050, 0403610053, 0403610054, 0403610055, 0403610057, 0403610061, 0403610062, 0403610063, 0404610061, 0404610062, 0404610063, 0404610063, 0404610064, 0404610064, 0404610065, 0404610065, 0404610070, 0404610070, 0404610071, 0404610071, 0404610072, 0404610072, 0405410037, 0405410038, 0405410039, 0432709078, 0432709079, 0432709079, 0432709080, 0432709081, 0432709082, 0432709083, 0432709083, 0432709084, 0432709084, 0433609001, 0433609001, 0433609002, 0433609002, 0433609005, 0433609005, 0433609062, 0434309100, 0434309101, 0434309103, 0434809001, 0434809003, 0434809004, 0434809005, 0434809006, 0434809007, 0434809007, 0434809008, 0434809008, 0434809012, 0434809013, 0434809014, 0434809014, 0434809015, 0434809015, 0434809016, 0434809016, 0434809017, 0434809017, 0434809018, 0434809018, 0434809019, 0434809019, 0436309084, 0436309085, 0436509122, 0436509123, 0436509124 & 0436509124.