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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 Recall
Siemens Axiom Luminos dRF solid state xray imager
see related information
Date Posted April 09, 2012
Recall Status1 Open
Recall Number Z-1383-2012
Recall Event ID 61483
Premarket Notification
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, Pennsylvania 19355
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Anastasia Mason
610-219-4834
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 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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