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Recall Observatory FDA recall evidence

Device product

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

Z-0036-2020

August 20, 2019

Class II

Product summary

Firm
Quality Electrodynamics LLC
Event
Event 83775
Status
Terminated
Classification
Class II
Quantity
36 units
Official record key
device-enforcement:Z-0036-2020

Official wording

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

Code information: 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

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.