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U.S. Department of Health and Human Services

Class 2 Device Recall Medical linear accelerator (with patient imaging)

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  Class 2 Device Recall Medical linear accelerator (with patient imaging) see related information
Date Initiated by Firm September 01, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on December 14, 2010
Recall Number Z-0350-2011
Recall Event ID 56753
510(K)Number K051932  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Synergy XVI

Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Code Information Serial Numbers 152019, 151866, 151259, 151522, 151969, 152192, 152126, 152115, 152116, 152176, 151931, 152177, 151523, 151626, 151842, 152158, 152079, 152080, 151250, 152064, 152207, 151628, and 151362
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
770-670-2548 Ext. 2374
Manufacturer Reason
for Recall		 It is possible to do couch corrections twice if both Couch Move Assistant in MOSAIQ and Remote Automatic Table in XVI are configured when in SYNERGISTIQ mode.
FDA Determined
Cause 2		 Other
Action Elekta sent an "Important Notice A340" dated September 1, 2010 to all customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to make a decision if XVI or MOSAIQ does the corrective table movement; configure and ensure that the system only uses RATM or CMA for the corrective table movement, when in SYNERGISTIQ mode, and complete and return the IMPORTANT NOTICE Confirmation of Receipt form via fax at +44(0)1293 654401. If you have any questions contact your local service representative at +44(0)1293 654200.
Quantity in Commerce 23 units
Distribution Nationwide distribution: AZ, CA, DC, IL, KY, MA, MI, MS, NV, NY, OH, OR, PA, VT, and WV.
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 = ELEKTA, INC
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