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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MQB
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