FDA Device Recall Z-0033-2020: Quality Electrodynamics LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0033-2020.

Recall Res Number

Z-0033-2020

Recalling Firm / Manufacturer

Quality Electrodynamics LLC

FEI Number

3007350713

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-08-20

Date Posted

N/A

Date Terminated

2020-05-26

Product Code

MOS

Event Number

83775

Product Quantity

5 units

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

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

Action Details The firm sent a notification letter to their customers who that have received the affected device. Customers were instructed to. 1. Immediately examine your inventory and quarantine product subject to recall. 2. if you have further distributed this product to MRI end users, please identify your affected customers and notify them. 3. Please ensure they understand to stop use of the coil for scanning and to notify you immediately.

Distribution Pattern Worldwide distribution - US in the states: NC OUS: Germany

Code Information / Serial Numbers Serial # 1308 1309 1310 1311 1313

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Medical Device Recall: Z-0033-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer