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U.S. Department of Health and Human Services

Class 2 Device Recall COHERENCE Oncologist

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  Class 2 Device Recall COHERENCE Oncologist see related information
Date Initiated by Firm January 16, 2020
Create Date February 21, 2020
Recall Status1 Terminated 3 on January 04, 2021
Recall Number Z-1346-2020
Recall Event ID 84795
510(K)Number K060633  
Product Classification Accelerator, linear, medical - Product Code IYE
Product COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Code Information Software versions 2.0.49, 2.0.50, 2.0.51
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Rebecca Tudor
610-219-4834
Manufacturer Reason
for Recall		 A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.
FDA Determined
Cause 2		 Software Design Change
Action The firm started notifying customers on January 16, 2020, with letters titled Urgent Medical Device Correction. Customers were advised of the product safety issue. To avoid the possibility of an incorrect alignment of the patient, the user must ensure that filtered images arrive on the COHERENCE Oncologist, or apply any additional filters to the image BEFORE using the "interactive shift" or "landmark registration" tools. The firm will be offering a software solution for the issue free of charge. The firm's letter stated that based on their investigation, customers may continue to use their devices.
Quantity in Commerce 64 Worldwide/26 Domestic
Distribution Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.
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 = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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