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Artis pheno- Model No. 10849000 recallZ-1646-2022 · Siemens Medical Solutions USA, Inc · initiated Aug 10, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

On 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: [email protected].

Recall details

Recall number
Z-1646-2022
Status
Open, Classified
Initiated by the company
Aug 10, 2022
Posted by the FDA
Aug 26, 2022
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
1,389 (590 US; 799 OUS) (Total)
Product code
OWB
FDA submissions
K220409
Distribution
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.

Product description

Artis pheno- Model No. 10849000

Code information (models, lots, serial numbers)

UDI-DI: 04056869046877 Serial Numbers 164766 164140 164138 164287 164740 164210 164183 164184 164776 164312 164071 164034 164391 164763 164306 164735 164277 164095 164072 164771 164743 164048 164741 164241 164186 164069 164213 164728 164263 164060 164113 164398 164366 164279 164774 164074 164084 164086 164098 164153 164330 164389 164394 164772 164718 164163 164297 164778 164333 164377 164397 164300 164105 164227 164022 164250 164739 164703 164187 164211 164100 164097 164775 164303 164352 164726 164724 164760 164371 ***Updated 9/23/22*** 164794 164400 ***Updated 1/9/23*** 164793 164172 164795

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 90771).

Sources and updates

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