Home / Recalls / Siemens Medical Solutions USA, Inc / Z-1647-2022

Z-1647-2022 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-1647-2022 was initiated by Siemens Medical Solutions USA, Inc on Aug 10, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1,389 (590 US; 799 OUS) (Total).

Recall Details

Product Type: Devices
Report Date: Sep 7, 2022
Initiation Date: Aug 10, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,389 (590 US; 799 OUS) (Total)

Product Description

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

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.

Distribution Pattern

Worldwide 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.

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1647-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.