Recall Z-0036-2020— Quality Electrodynamics LLC

Name: FDA recall Z-0036-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-20

Class II · Terminated

Class II FDA medical device recall by Quality Electrodynamics LLC, initiated 2019-08-20, terminated 2020-05-26. It names one FDA 510(k) clearance: K082636. Product: TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828. Reason: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils..

Recalling firm: Quality Electrodynamics LLC
Classification: Class II
Status: Terminated
Initiated: 2019-08-20
Terminated: 2020-05-26
Firm location: Mayfield Village, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K082636 — TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3TQuality Electrodynamics·cleared 2008-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.