FDA Recall Terminated

The I-Cart is used to store, transport, and power video equipment used in medical procedures.

Recall: Z-1240-2015 · Initiated December 10, 2014

Recall

Recall Number
Z-1240-2015
Event Number
70220
Firm
Richard Wolf Medical Instruments Corp.
FEI Number
1418479
Product Code
KMI
Status
Terminated
Root Cause
Device Design
Initiated
December 10, 2014
Posted
March 3, 2015
Terminated
July 31, 2017
Address
353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110

Description

The I-Cart is used to store, transport, and power video equipment used in medical procedures.

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.

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.

Distribution

Nationwide

Quantity

83 carts