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Terminated

Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems

FDA Recall Z-1770-2017 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2016-10-17
Date Terminated2017-10-24
Product Quantity3 systems distributed in the U.S.

Reason for Recall

Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.

Firm Action

Siemens mailed an Customer Safety Advisory Notice on October 17, 2016, to all affected customers to inform them of the corrective action they plan to take to correct the issue. The notice also informed users of the possible risks to patients and how the corrective action will be implemented. For further questions, please call (610) 448-6461.

Root Cause

Software design (manufacturing process)

Distribution Pattern

US Distribution to: DC and MD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101347MAGNETOM AERA; MAGNETOM SKYRASiemens Medical Solutions USA, Inc. · 2010-10-01

Official Source

View FDA Recall →

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

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