Recall Z-1240-2015 ยท KMI Monitor, Bed Patient
Richard Wolf Medical Instruments Corp.
The I-Cart is used to store, transport, and power video equipment used in medical procedures.
| Date | Mar 3, 2015 (initiated Dec 10, 2014) |
| Status | Terminated |
| Reason | The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis. |
| Root cause | Device Design |
| Action | Field Action Notice letters dated December 10, 2014 were sent to both direct accounts (customers). The letters instructed customers to: 1) Instruct the biomed to bypass the integrated power grid on the cart and not to use the electrical system on the affected carts until a qualified Omni Corporation service technician is able to inspect and repair the carts; and 2) Omni Corporation will schedule a qualified Omni field service technician, in conjunction with Richard Wolf and the customer's biomed unit, to visit and replace the transformer on the cart. |
| Quantity | 83 carts |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.