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U.S. Department of Health and Human Services

Class 2 Device Recall SPECT/CT System Torque wrench

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 Class 2 Device Recall SPECT/CT System Torque wrenchsee related information
Date Initiated by FirmSeptember 18, 2017
Create DateOctober 25, 2017
Recall Status1 Terminated 3 on December 11, 2017
Recall NumberZ-0047-2018
Recall Event ID 78086
510(K)NumberK162337 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductTorque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
Code Information Symbia T2 serial number 2001; Symbia Intevo Excel serial numbers 2112 and 2140; Symbia Intevo 16 serial numbers 2100 and 2116; Symbia Evo serial numbers 1049, 1054, 1071, 1075, 1104, and 1128; and Symbia Evo Excel serial numbers 1109, 1111, 1131, 1134, and 1158.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates IL 60192-2061
For Additional Information ContactLaura Meyers
847-217-2734
Manufacturer Reason
for Recall		The torque wrench used to tighten system bolts during installation was found to be out of tolerance
FDA Determined
Cause 2		Equipment maintenance
ActionThe recall was initiated via phone and visit beginning 9/18/2017.
Quantity in Commerce16 devices
DistributionDistribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution.
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 = KPS
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