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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM go.All

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 Class 2 Device Recall SOMATOM go.Allsee related information
Date Initiated by FirmJuly 31, 2019
Create DateAugust 28, 2019
Recall Status1 Terminated 3 on December 02, 2020
Recall NumberZ-2403-2019
Recall Event ID 83556
510(K)NumberK173632 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactRebecca Tudor
610-219-4834
Manufacturer Reason
for Recall		The injector holder could potentially fall off together with the injector and the storage box.
FDA Determined
Cause 2		Nonconforming Material/Component
Action1. Take special care when rotating the injector and storage box horizontally 2. Your Siemens Healthineers service engineer will perform an on-site check to evaluate the stability of the injector arm. 3. If there is any problem with the injector arm, your Siemens Healthineers service engineer will replace the injector arm with an improved intermediate version free of charge. 4. Please ensure all users of the affected products are aware. 5. Retain this notification in your product related records and place a copy in the medical device's instructions for use. 6. If you have distributed this product, identify your customers and notify them. If you wish to request an earlier appointment or have additional questions, feel free to contact service organization at 1-800-888-7436 .
Quantity in Commerce0
DistributionUS Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD
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 = JAK
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