Agency classClass IIOur severity:High FDA (Devices)·Z-0708-2018·Announced 2018-03-07

Siemens Axiom Artis Medical Devices Recalled for Liquid Entry Risk

Siemens Medical Solutions is recalling Axiom Artis devices due to a potential for liquid entry.

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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Axiom Artis medical devices, including model numbers 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, and 7728392. The recall is issued because of a potential for liquid entry into the devices.

The affected units were distributed nationwide in the United States. The source text does not specify the number of units recalled, the specific dates of distribution, or any reported illnesses or injuries associated with this defect.

Healthcare facilities and consumers should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and potential remediation of the affected devices.

The recalled product

Product: Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: liquid-entry

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 (20)

10094135
10094137
10094141
10094142
10094143
10280959
10848280
10848281
10848282
10848353
10848354
10848355
5904433
5904441
5904649
5904656
5917054
7007755
7008605
7412807

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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