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Recall Observatory FDA recall evidence

Device product

TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829

Z-0037-2020

August 20, 2019

Class II

Product summary

Firm
Quality Electrodynamics LLC
Event
Event 83775
Status
Terminated
Classification
Class II
Quantity
21 units
Official record key
device-enforcement:Z-0037-2020

Official wording

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

Code information: Serial # 1288 1466 2149 2570 2571 2573 2574 2575 2576 2577 2578 2579 2580 2581 2582 2583 2584 2585 ¿1029 1179 ¿1356

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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