Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0769-06

Storz Documentation Cart with Articulating Arm, Model Number 9601F

Karl Storz Endoscopy-America, Inc. / initiated 2006-03-10 / Terminated / root cause: manufacturing process

Karl Storz Endoscopy America Inc began a recall of Storz Documentation Cart with Articulating Arm, Model Number 9601F on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0769-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Karl Storz Endoscopy-America, Inc.
Product
Storz Documentation Cart with Articulating Arm, Model Number 9601F
Product code
KOG
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.
Root cause tag
manufacturing process
FDA root cause
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
Product codes and lots
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