Z-0232-2016 Class II Terminated
FDA device recall Z-0232-2016 was initiated by Boston Scientific Corporation on Sep 17, 2015 and is designated Class II. Reason for recall: Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of… The recall status is terminated (terminated Mar 8, 2016). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 18, 2015
- Initiation Date
- Sep 17, 2015
- Termination Date
- Mar 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Reason for Recall
Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte
Distribution Pattern
Distributed in the US to MA and PR.
Code Information
A019995 A020132 A020240
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0232-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026