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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Digital Linear Acceletators

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 Class 2 Device Recall Siemens Digital Linear Acceletatorssee related information
Date Initiated by FirmMay 28, 2014
Date PostedAugust 10, 2014
Recall Status1 Terminated 3 on July 23, 2015
Recall NumberZ-2174-2014
Recall Event ID 68507
510(K)NumberK031764 K072485 K790688 K982502 
Product Classification Accelerator, linear, medical charged-particle radiation therapy system - Product Code IYE
ProductSiemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
Code Information material numbers: 01940035, 04504200, 05672977, 05693908, 05857912, 05857920, 08139789, 08319758, 08490005, 08515520, 09401654, 09401746, 09822693, with serial numbers below 3094.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactCustomer Support
610-219-6300
Manufacturer Reason
for Recall		A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
FDA Determined
Cause 2		Use error
ActionAn Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users.
Quantity in Commerce160
DistributionNationwide and ROW, including Canada and Mexico.
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 = IYE
510(K)s with Product Code = IYE
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