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Terminated

Storz Documentation Cart with Articulating Arm, Model Number 9601F

FDA Recall Z-0769-06 · Posted 2006-04-19

Recalling FirmKarl Storz Endoscopy America Inc
Recall StatusTerminated
Product CodeKOG
Date Initiated2006-03-10
Date Terminated2008-08-07
Product Quantity333

Reason for Recall

THE ARTICULATING ARM ON THE CART, WHICH HOLDS THE MONITOR, MAY FALL OFF FROM THE CART DURING MANIPULATION. WHEN IT FALLS, IT COULD HIT THE GROUND OR FALL ON THE PEOPLE/OBJECTS THAT ARE IN CLOSE PROXIMITY.

Firm Action

Alert letter mailed 03/10/2006 via FedEx to all direct accounts. The firm was instructed to complete the Customer Response Form, which included a box to be checked for who will do the correction (The Customer or The Firm), and fax it back. After the correction is completed, the firm is to fax the Customer Response form a second time completing part 2 of the form.

Root Cause

Process control

Distribution Pattern

NATIONWIDE

Official Source

View FDA Recall →

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

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