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ARTIS icono floor-Angiography systems developed for single… recallZ-2360-2023 · Siemens Medical Solutions USA, Inc · initiated Jun 19, 2023

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

Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

FDA root cause category: Process control

What the company is doing

Siemens issued Urgent: Medical Device Correction to all users of ARTIS icono/ ARTIS pheno systems with a specific Polydoros ACX power generator on 6/19/23. Letter states reason for recall, health risk and action to take: It is strongly recommended to establish appropriate emergency procedures until the corrective action has been performed. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Siemens will correct the hardware error via Update Instruction AX008/23/S. This measure will correct the Polydoros ACX reactor coil of all affected systems. Our service organization will contact you 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. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein

Recall details

Recall number
Z-2360-2023
Status
Open, Classified
Initiated by the company
Jun 19, 2023
Posted by the FDA
Aug 8, 2023
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
7 units
Product code
OWB
FDA submissions
K220432
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Latvia, Luxembourg, Macedonia, Mexico, Monaco, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

Product description

ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700

Code information (models, lots, serial numbers)

UDI-DI: 4056869149325 Serial Numbers: 170561 170549 170559 170546 170552 170571 170570

Devices named in this recall

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

Other devices under the same FDA submission

1 device cleared under K220432 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92653).

Sources and updates

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