Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)
This recall has been terminated (originally issued December 17, 2010).
- Recall Initiated
- October 25, 2010
- Posted
- December 17, 2010
- Terminated
- September 29, 2012
- Recall Number
- Z-0717-2011
- Quantity
- 24 units
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
patient leg can be pinched
Distribution
Nationwide distribution: CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NJ, and NY.
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.
Root Cause
Other
Action Taken
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.