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

FDA device recall Z-1240-2015 · posted 2015-03-03 · Terminated

Recall details

Recalling firm

Richard Wolf Medical Instruments Corp.

Reason for recall

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 taken

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.

Root cause

Device Design

Status

Terminated

Product code

KMI

Quantity affected

83 carts

Distribution

Nationwide

Date initiated

2014-12-10

Date posted

2015-03-03

Date terminated

2017-07-31

Location

Vernon Hills, IL