Recalls / —

—#150229

Product

Aptio Automation Modules

FDA product code

JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Siemens Healthcare Diagnostics, Inc.

Address

500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern

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

Timeline

Recall initiated

2016-09-29

Terminated

2018-09-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #150229. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.