FDAClass IINovember 23, 2016

Aptio Automation Modules recall

Aptio Automation Modules

Why was Aptio Automation Modules recalled?

Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Aptio Automation Modules
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
448 units
Distribution
Distributed Nationwide and to the following countries: Australia, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Germany, Greece, Indonesia, Italy, Kingdom Saudi Arabia, Lebanon, Malaysia, P.R. China, Philippines, Portugal, Qatar, Republic Korea, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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