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Artis Q, Angiographic x-ray system recallZ-0601-2017 · Siemens Medical Solutions USA, Inc · initiated Nov 1, 2016

Class II Terminated All recalls posted in November 2016

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

The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.

FDA root cause category: Software in the Use Environment

What the company is doing

Siemens mailed a Customer Safety Advisory Notice to affected customers to inform them of a corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice identified the associated risks, underlying issues, impact on system operation and actions to be taken.

Recall details

Recall number
Z-0601-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 1, 2016
Posted by the FDA
Nov 17, 2016
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
4,657 systems (worldwide)
Product code
OWB
FDA submissions
K123529
Distribution
US Nationwide Distribution.

Product description

Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

Code information (models, lots, serial numbers)

Model Numbers: 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355

Other devices under the same FDA submission

7 devices cleared under K123529 — the recall does not name any of them by identifier. 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 75606).

Sources and updates

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