FDA Device

Aptio Automation Modules

Hazard

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

What You Should Do

Remedy

Siemens mailed to customers an Urgent Field Safety Notification letter warning them of the problem and to inform them that Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords.

Products

Aptio Automation Modules
Brand
Siemens Healthcare Diagnostics, Inc.
UPC
"Refrigerated Storage Module (RSM): 10703049, 10715227, 10703036, 10713762, 10713767; "Centrifuge Module (CM): 10703032, 10713761, 10713764; "i2000SR Interface Module (i2000SR): 10989303, 10989304.

Units Affected

448 units