FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Aptio Automation Modules
- Recall number
- Z-0590-2017
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Aptio Automation Modules
- Status
- Terminated
- Initiated
- 2016-09-29
- Posted
- not on file
- Terminated
- 2018-09-19
- Reason
- Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.
- Root cause
- Under Investigation by firm
- Action
- 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.
- 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
- Lot, serial or model codes
- "Refrigerated Storage Module (RSM): 10703049, 10715227, 10703036, 10713762, 10713767; "Centrifuge Module (CM): 10703032, 10713761, 10713764; "i2000SR Interface Module (i2000SR): 10989303, 10989304.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28