Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1489-2017·Announced 2017-03-29

Siemens Recalls 80 Mevatron M2/Primus Mid-Energy Systems for Software Update

Siemens Medical Solutions USA is recalling 80 Mevatron M2/Primus Mid-Energy systems to apply a software update. The recall was initiated voluntarily by the firm.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The reason for recall is a software update, which is often a precautionary or corrective measure rather than a response to a severe, immediate hazard like a structural defect or reported serious injury.

Plain-English summary

Siemens Medical Solutions USA, Inc. is voluntarily recalling 80 Mevatron M2/Primus Mid-Energy PRIMUS HI systems. The recall was initiated on February 14, 2017, and the devices are identified by Model Numbers 1940035 and 4504200. The stated reason for the recall is a software update.

The affected systems were distributed throughout the United States. The recall was classified as Class II by the FDA and was initiated by the firm. The recall status is currently terminated, with a termination date of December 18, 2017.

Healthcare facilities and users of these systems should verify if they possess the affected model numbers. As the recall is terminated, the specific corrective actions or software updates have likely been completed or the recall process has concluded. Users should consult their Siemens representative or the FDA recall notice for specific technical details regarding the software update.

The recalled product

Product: Mevatron M2/Primus Mid-Energy PRIMUS HI
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiology Equipment
Hazard: software-defect
Affected units: 80

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 (2)

Device Model# 1940035
4504200

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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