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Terminated

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

FDA Recall Z-1240-2015 · Posted 2015-03-03

Recalling FirmRichard Wolf Medical Instruments Corp.
Recall StatusTerminated
Product CodeKMI
Date Initiated2014-12-10
Date Terminated2017-07-31
Product Quantity83 carts

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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