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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Artis Q biplane

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 Class 2 Device Recall Siemens Artis Q biplanesee related information
Date Initiated by FirmJune 06, 2019
Create DateJune 28, 2019
Recall Status1 Terminated 3 on February 09, 2021
Recall NumberZ-1900-2019
Recall Event ID 83082
510(K)NumberK181407 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductSiemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
Code Information Serial Numbers: 121013 121057 121056 121058 121006 121185 121016 121027 121020 121321 121448 121040 121049 121015 121094 121082 121089 121383 121144 121319 121137 121085 121155 121193 121136 121165 121140 121141 121151 121168 121169 121154 121211 121188 121415 121183 121209 121187 121309 121200 121313 121206 121361 121366 121359 121393 121301 121407 121406 121352 121379 121364 121342 121471 121520 121411 121412 121402 121430 121502 121421 121472 121460 121457 121515 121444 121516 121510 121491 121525 121530 121527 
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactSAME
610-219-4834
Manufacturer Reason
for Recall		Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
FDA Determined
Cause 2		Device Design
ActionSiemens issued letter dated 6/6/19 advising of the problem, health risk and action to take: .Siemens is implementing a corrective action to all potentially affected users via Update Instruction AX023/18/S. Siemens Service organization will replace the screwed connection of the ceiling support according to specifications / instructions. In the event the bolt connection cannot be replaced due to technical conditions, the complete bearing will be replaced.
Quantity in Commerce73
DistributionNationwide
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 = OWB
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