FDA Device recall Z-0212-2019
APTIO 15000 REFRIGERATED STORAGE MODULE
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of APTIO 15000 REFRIGERATED STORAGE MODULE by Siemens Healthcare Diagnostics, citing the modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0212-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-14 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | 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, WV |
Product
APTIO 15000 REFRIGERATED STORAGE MODULE
Reason
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Identifiers
| code_info | Siemens Material Numbers: 10703036, 10713762; UDI: 00630414594477 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0212-2019%22
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