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Terminated

(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system

FDA Recall Z-0374-2014 · Posted 2013-11-26

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPR
Date Initiated2013-09-03
Date Terminated2015-02-24
Product Quantity357

Reason for Recall

A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.

Firm Action

Siemens Healthcare sent a Field Safety Notice dated September 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Field Safety Notice to any new users and provide the new owner information to Siemens Healthcare. Customers were asked to send back the attached form confirming receipt of the Field Safety Notice. Customers with questions should call 610-850-4634. For questions regarding this recall call 610-219-6300.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111292LUMINOS AGILESiemens Medical Solutions USA, Inc. · 2011-06-03K101491UROSKOP OMNIASiemens Medical Solutions USA, Inc. · 2010-06-30K081722YSIOSiemens Medical Solutions USA, Inc. · 2008-08-22K062623AXIOM LUMINOS DRFSiemens Medical Solutions USA, Inc. · 2007-08-22

Official Source

View FDA Recall →

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

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