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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 Device Recall Axiom Luminos dRFsee related information
Date Initiated by FirmOctober 25, 2010
Date PostedDecember 17, 2010
Recall Status1 Terminated 3 on September 29, 2012
Recall NumberZ-0717-2011
Recall Event ID 57311
510(K)NumberK062623 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductAxiom 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 PA 19355
For Additional Information ContactMeredith Adams
610-448-3237
Manufacturer Reason
for Recall		patient leg can be pinched
FDA Determined
Cause 2		Other
ActionSIEMENS 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 Commerce24 units
DistributionNationwide distribution: CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NJ, and NY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MQB
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