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Terminated

Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.

FDA Recall Z-1390-05 · Posted 2005-08-23

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeDZJ
Date Initiated2005-08-05
Date Terminated2005-10-26
Product Quantity27

Reason for Recall

Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.

Firm Action

U.S. customer was notified via recall letter dated August 5, 2005 and international affiliates were notified via email. U.S. account was requested to return the product.

Root Cause

Other

Distribution Pattern

Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040369STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMStryker Instruments · 2004-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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