FDA Device Recall Z-0036-2020: Quality Electrodynamics LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0036-2020.

Recall Res Number

Z-0036-2020

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

36 units

Product Description TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828

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 # 1694 1841 1887 1933 1998 3195 3291 3292 3293 3294 3298 3299 3300 3301 3302 3303 3304 3305 3306 3307 3308 3309 3310 3311 3312 3313 3314 3315 3316 3317 3318 ¿1137 ¿1361 ¿1378 ¿1628 ¿2447

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Medical Device Recall: Z-0036-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer