FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: APTIO 9000 REFRIGERATED STORAGE MODULE
- Recall number
- Z-0213-2019
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- APTIO 9000 REFRIGERATED STORAGE MODULE
- Status
- Terminated
- Initiated
- 2018-08-14
- Posted
- not on file
- Terminated
- 2020-09-04
- Reason
- The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
- Root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Correction notification letters dated 8/14/18 were distributed to customers.
- Quantity
- 441 Aptio Automation Modules
- Distribution
- The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.
- Lot, serial or model codes
- Siemens Material Numbers: 10703049, 10715227; UDI: 00630414594477
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXG
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- 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