FDA Recall
Terminated
Storz Documentation Cart with Articulating Arm, Model Number 9601F
Recall: Z-0769-06
·
Initiated March 10, 2006
Recall
- Recall Number
- Z-0769-06
- Event Number
- 35048
- Firm
- Karl Storz Endoscopy America Inc 600 Corporate Pointe
- FEI Number
- 2020550
- Product Code
- KOG
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 10, 2006
- Posted
- April 19, 2006
- Terminated
- August 7, 2008
- Address
- Culver City, CA, 90230-7600
Description
Storz Documentation Cart with Articulating Arm, Model Number 9601F
Reason
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.
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.
Distribution
NATIONWIDE
Quantity
333