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Terminated

Stryker Medical Epic II Critical Care Bed, 115 V, Stryker Medical, Portage, MI.; Model 2030.

FDA Recall Z-1686-2008 · Posted 2008-09-19

Recall StatusTerminated
Product CodeFNL
Date Initiated2008-02-01
Date Terminated2010-11-05
Product Quantity66,558 of all models.

Reason for Recall

The brakes may not have adequate holding power to lock the bed in place.

Firm Action

Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.

Root Cause

Device Design

Distribution Pattern

Worldwide, Argentina, Brazil, Canada, Chile, China, Greece, India Japan, Mexico, Poland, Singapore, South Africa, South Korea, Switzerland, Taiwan and United Kingdom.

Official Source

View FDA Recall →

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

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