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Terminated

TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

FDA Recall Z-0035-2020 · Posted None

Recalling FirmQuality Electrodynamics LLC
Recall StatusTerminated
Product CodeMOS
Date Initiated2019-08-20
Date Terminated2020-05-26
Product Quantity5 units

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082636TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3TQuality Electrodynamics · 2008-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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