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U.S. Department of Health and Human Services

Class 2 Device Recall Artis icono

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 Class 2 Device Recall Artis iconosee related information
Date Initiated by FirmAugust 10, 2022
Date PostedAugust 26, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1647-2022
Recall Event ID 90771
510(K)NumberK220432 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductArtis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Code Information Artis icono biplane- Model No. 11327600 UDI-DI: 04056869063317 Serial Numbers 180062 180054 180019 180421 180444 180034 180072 180446 180367 180438 180382 180060 180428 180369 180370 180371 180372 180080 180301 180305 180067 180399 180442 180040 180379 180386 180360 180333 180352 180407 180433 180412 180400 180397 180432 180316 180447 180363 180429 180084 180418 180334 180018 180376 180354 180046 180434 180357 180358 180361 180362 180081 180423 180411 180414 180381 180021 180443 180309 180356 180378 180393 180368 180413 180323 180439 180445 180430 180043 180437 180049 180377 180077 180055 180014 180037 180373 ***Updated 9/23/22*** 180466 180465 180464 180047 180463 ***Updated 1/9/23*** 180470 180534 180468 180472 180467 180469 180066 180082 Artis icono floor- Model No. 11327700 UDI-DI: 04056869149325 Serial Numbers 170319 170391 170392 170397 170026 170388 170343 170367 170368 170360 170349 170361 170383 170322 170385 170386 170025 170384 170346 170051 170358 170389 170357 170365 170387 170390 170393 170394 170378 170396 170053 170364 ***Updated 1/9/23*** 170402
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMeredith Adams
610-219-4834
Manufacturer Reason
for Recall		Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
FDA Determined
Cause 2		Device Design
ActionOn August 10, 2022, the firm notified customers via "URGENT: MEDICAL DEVICE CORRECTION" Letter. Customers were advised that if the error occurs, the user should try to recover normal operation by a shutdown and restart of the system. Siemens will correct the error with a hardware modification via Update Instruction AX028/22/S and AX039/22/S. Siemens' service organization will contact customers shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. If you have any further questions, call 610-219-4834 or email: meredith.adams@siemens-healthineers.com.
Quantity in Commerce1,389 (590 US; 799 OUS) (Total)
DistributionWorldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Algeria; Estonia; Egypt; Spain; Finland; France; United Kingdom; Greece; Guatemala; Hong Kong; Croatia; Inhouse Company; Indonesia; Ireland; Israel; India; Iran; Italy; Jordan; Japan; South Korea; Kuwait; Kazakhstan; Lebanon; Luxembourg; Monaco; Mongolia; Martinique; Mexico; Malaysia; Netherlands; Norway; New Zealand; Oman; Philippines; Poland; Portugal; Qatar; Serbia; Russian Federation; Saudi Arabia; Sweden; Singapore; Slovenia; Slovakia; El Salvador; Thailand; Turkey; Taiwan; Ukraine; Vietnam and South Africa.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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