Recalls / —

—#95819

Product

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

FDA product code

MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K062623

Affected lot / code info

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.

Why it was recalled

patient leg can be pinched

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

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

Timeline

Recall initiated

2010-10-25

Posted by FDA

2010-12-17

Terminated

2012-09-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #95819. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.