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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Luminos dRF

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 Class 2 Recall
Axiom Luminos dRF
see related information
Date Posted December 17, 2010
Recall Status1 Terminated on September 29, 2012
Recall Number Z-0717-2011
Recall Event ID 57311
Premarket Notification
510(K) Number
K062623 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)
Code Information 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.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Meredith Adams
610-448-3237
Manufacturer Reason
for Recall
patient leg can be pinched
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Quantity in Commerce 24 units
Distribution Nationwide distribution: CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NJ, and NY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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