FDA Device recall Z-1178-2017
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer by Boston Scientific, citing there is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1178-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-12 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Reason
There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.
Identifiers
| code_info | All serial numbers. |
|---|
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-1178-2017%22
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