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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 10, 2006
Date Posted April 19, 2006
Recall Status1 Terminated 3 on August 07, 2008
Recall Number Z-0769-06
Recall Event ID 35048
Product Classification unknown device name - Product Code KOG
Product Storz Documentation Cart with Articulating Arm, Model Number 9601F
Code Information Serial numbers:  82861-8 84504-21 84505-10 84505-30 84987-15  82859-4  82859-5  82859-6  82859-7  82858-8  82858-9  82858-10  81553-1 85358-35 80486C-9 84505-14  82861-1  82861-2  82861-3  82861-4  82861-5 80486C-17 81553-14 81553-20  84987-17  84987-18  84987-19  84987-20  84987-21  84987-22  84987-23  84987-24  84987-34 84987-35 84504-20 84504-24 85358-9 80485-1  80485-2 81552-11 81552-10 81553-19 85358-37 80486C-1 80486C-2 84505-12 82858-4 82858-5 82858-6 82858-7  84987-6  84987-7  84987-8  84987-9  84987-10  84987-11  84504-17  84504-18  84504-19  84505-19  84505-20  84505-21  84505-16  84505-17  84505-18 85358-41 84504-28 82859-3  82859-2  80486C-3  80486C-4  80486C-5  80486C-6 80486C-6  84504-9  84504-10 82861-10  82861-9 81553-6  81553-7 81552-37 81552-19 81552-18  84505-27  84505-28 85358-40 82861-7 82861-6 82860-1  84987-1  84987-2 84505-7 81553-18 81553-18 84987-3 84987-16 84504-26  85358-15  85358-16  85358-17  85358-18  85358-19  85358-20  85358-38  85358-39  85358-1  85358-2  85358-3  85358-4  85358-5  85358-6 80486C-8 85358-21 84505-24 84505-9 81552-14 81552-15 81552-16 80486C-14 81552-17  82860-2  82860-3  82860-4  82860-5  85358-33  85358-34  85358-48  85358-49  85358-50  84505-1  84505-2  84505-3  84505-4  85358-45  85358-46  85358-47 81552-22  81552-23  81552-24  81552-25  81552-26  81552-27  81552-28  81552-29  81552-30  81552-31  81552-32  81552-33  81552-34  81552-35   81553-8  81553-9 81552-4 81552-3 80485-7 82859-1 81553-3 81553-2 80486C-7 81553-10 81552-5 80486C-16 81552-6  80484B-16  80484B-17  80484B-18  80484B-19 80485-3 80485-4 82860-9 82858-1  80484B-6  80484B-7  80484B-8  80484B-9  80484B-10  80484B-11  80484B-12  80484B-13  80484B-14  80484B-15 84957A-1 84957A-3 84957A-5 84957A-4 84957A-7 84957A-2 84957A-6 84504-25  85358-8  85358-9  80486C-11  80486C-12 81553-13  82860-6  82860-7  82860-8 80485-8 80485-9  80485-10 84505-8 80484B-20 81553-4  81553-5 82858-3  85358-26  85358-27  85358-28  85358-29  85358-30  85358-31  85358-32 84987-5 84987-4 81553-15 81553-16 84505-15  85358-10  85358-11  85358-12  85358-13 84504-16  84505-22  84505-23  85358-42  85358-43  85358-44 84504-29 81552-13 80485-5  80485-6  84504-11  84504-12  84504-13  84504-14  84504-15 80486C-19 80486C-20 84505-13 84987-12 84987-28 84987-29 84987-30 84987-31 84987-32 84987-33 84987-3 84987-3 86058-1 86058-2 86058-3 86058-4 86058-5 86058-6 86058-7 86058-8 84987-25 84987-26 84987-27 84987-13 84987-14 86058-11 86058-10 86058-9 86058-12 86058-13 86058-14 86058-15 86747-1 86747-2 86747-3 86747-4 86747-5 86747-6 86747-7 86747-8 86747-9 86747-10 86058-18 86058-17 86747-12 86747-13 86747-14 86747-15 86747-16 86747-11 86747-17 86747-18 86747-29 86747-30 86747-28 86747-21 86747-22 86747-23 86747-24 86747-20 86747-27 86747-31 86747-32 86747-33 86747-34 86747-35 86747-39 86747-38 86747-37 86747-36 86747-49 86747-50 86747-48 86747-46 86747-47 86747-43 86747-44 86747-45 86747-42 86058-2 86058-3 84987-36 84987-37 86058-1 82859-9  82859-10 84504-1  84504-3  84504-4  84504-5  84504-6  84504-7  84504-8  84504-2  
Recalling Firm/
Manufacturer
Karl Storz Endoscopy America Inc
600 Corporate Pointe
Culver City CA 90230-7600
For Additional Information Contact Emily Cuadros
800-421-0837 Ext. 4289
Manufacturer 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.
FDA Determined
Cause 2
Process control
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.
Quantity in Commerce 333
Distribution NATIONWIDE

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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