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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Axiom Luminos dRF solid state xray imager

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  Class 2 Device Recall Siemens Axiom Luminos dRF solid state xray imager see related information
Date Initiated by Firm February 16, 2012
Date Posted April 09, 2012
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-1383-2012
Recall Event ID 61483
510(K)Number K062623  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Siemens Axiom Luminos dRF solid state x-ray imager

Solid state x-ray imager (flat panel/dig. imager)
Code Information Model number 10094200, serial numbers 3019 and 1358
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 During regular product monitoring, Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibration of the wrench, it was discovered that the wrench was out of the specification. The wrench was over-torquing approximately 21% for low-end readings (50 ftlbs) and 9% for high-end readings (250
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens initiated a recall/correction on February 16, 2012 by issuing Update Instruction XP056/11/S to the affected customers. All screws on the unit support on AXIOM Luminos dRF units will be replaced by a Siemens service engineer. For information regarding this recall call 610-219-4834.
Quantity in Commerce 2
Distribution Nationwide Distribution including California
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MQB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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