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Class 2 Device Recall Medical linear accelerator (with patient imaging) |
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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
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Product Classification |
Accelerator, linear, medical - Product Code IYE
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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
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For Additional Information Contact |
Thomas Valentine 770-670-2548 Ext. 2374
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = ELEKTA, INC
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