FDA Device

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

Hazard

patient leg can be pinched

What You Should Do

Remedy

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.

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Products

Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)
Brand
Siemens Medical Solutions USA, Inc
UPC
Model number 10094200. Serial numbrs: 1148, 1149, 1182, 1191, 1194, 1221, 1224, 1250, 1265, 1316, 1327, 1358, 1410, 1419, 1443, 2022, 2024, 2025, 2049, 2054, 2069, 2070, 2076, and 2092.

Units Affected

24 units

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