Medical device recalls Moderate risk

Quality Electrodynamics LLC recalls TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464

Recall date
August 20, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0033-2020
FDA classification
Class II
Brand / firm
Quality Electrodynamics LLC
Sold / distributed
Worldwide distribution - US in the states: NC OUS: Germany

Why it was recalled

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464

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