Recall Z-0769-06 ยท KOG
Karl Storz Endoscopy America Inc
Storz Documentation Cart with Articulating Arm, Model Number 9601F
| Date | Apr 19, 2006 (initiated Mar 10, 2006) |
| Status | Terminated |
| 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. |
| 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 | 333 |
| Distribution | NATIONWIDE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.