TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
This recall has been terminated (originally issued August 20, 2019).
- Company
- Quality Electrodynamics Llc
- Recall Initiated
- August 20, 2019
- Terminated
- May 26, 2020
- Recall Number
- Z-0036-2020
- Quantity
- 36 units
- Firm Location
- Mayfield Village, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Distribution
Worldwide distribution - US in the states: NC OUS: Germany
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.