Agency classClass IIOur severity:Severe FDA (Devices)·Z-0590-2017·Announced 2016-11-23

Siemens Aptio Automation Modules Recalled for Overheating Power Cord Plugs

Siemens Healthcare Diagnostics is recalling 448 Aptio Automation Modules because power cord plugs may overheat when connected to FlexLab and Aptio systems.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a potential fire hazard (overheating power cords) which aligns with the 'Severe' criteria for significant injury or property-damage reports, even if specific incidents are not detailed in the brief source text.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 448 units of Aptio Automation Modules. The recall involves specific Refrigerated Storage Modules, Centrifuge Modules, and i2000SR Interface Modules.

The recall is being issued because the power cord plugs used to connect these modules to FlexLab and Aptio Automation systems may overheat. This overheating presents a potential fire or burn hazard.

The affected units were distributed nationwide in the United States and to numerous international countries, including Australia, Canada, Germany, and the United Kingdom. Users of these modules should stop using the affected power cord plugs and contact Siemens Healthcare Diagnostics for instructions on how to proceed.

The recalled product

Product: Aptio Automation Modules
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — Laboratory Automation
Hazard: fire
burn-injury
Affected units: 448

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 (10)

"Refrigerated Storage Module (RSM): 10703049
10715227
10703036
10713762
10713767
"Centrifuge Module (CM): 10703032
10713761
10713764
"i2000SR Interface Module (i2000SR): 10989303
10989304.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Siemens Healthcare Diagnostics, 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 Healthcare Diagnostics, Inc.

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