Agency classClass IIOur severity:High FDA (Devices)·Z-0972-2017·Announced 2017-01-18

Siemens Recalls Artis Q Angiographic X-Ray Systems for Generator Defects

Siemens is recalling Artis Q angiographic x-ray systems due to potential high-voltage generator failures and rare image display loss.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device with a potential for significant operational failure (high-voltage generator module failure) and loss of critical diagnostic imaging, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling approximately 1,500 Artis Q and Q.zen angiographic x-ray systems distributed worldwide. The recall addresses two independent potential causes of system defects.

First, in systems equipped with A100 Plus or A100G generators, attempting to resume operation after a fault detection can cause a module in the high-voltage generator to fail. Second, for biplane systems delivered with software version VD11B since April of this year, software issues combined with graphics card problems may rarely result in the loss of image display in the examination room.

The affected models include units with model numbers 10848280, 10848281, 10848282, 10848353, 10848354, and 10848355. These systems are used for various diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography. Healthcare facilities should contact Siemens to arrange for corrective action to address these defects.

The recalled product

Product: Artis Q/Q.zen, Angiographic x-ray system Stand alone system 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.…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging
Hazard: equipment-failure
loss-of-function
Affected units: 1,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Model # 10848280
10848281
10848282
10848353
10848354
10848355

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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