Z-0036-2020 Class II Terminated
FDA device recall Z-0036-2020 was initiated by Quality Electrodynamics LLC on August 20, 2019 and is designated Class II. Reason for recall: Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. The recall status is terminated (terminated May 26, 2020). Affected quantity: 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- August 20, 2019
- Termination Date
- May 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
Distribution Pattern
Worldwide distribution - US in the states: NC OUS: Germany
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