Storz Documentation Cart with Articulating Arm, Model Number 9601F
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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
