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Terminated

Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)

FDA Recall Z-0717-2011 · Posted 2010-12-17

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2010-10-25
Date Terminated2012-09-29
Product Quantity24 units

Reason for Recall

patient leg can be pinched

Firm Action

SIEMENS sent a Customer Safety Advisory Notice dated October 25, 2010, to affected customers via Update Instructions AX072/10/S. The notice described the issue and the actions to be taken by customers. The customers were instructed to retain the annex together with their operating instructions and bring the hazard to the attention of their employees; inform all users and other persons of this notice; if they sold the device, forward this notice and attachment to the new owners of the device and provide SIEMENS with details of the new owners. If you have any questions, please contact +1-888-826-9702.

Root Cause

Other

Distribution Pattern

Nationwide distribution: CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NJ, and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062623AXIOM 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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