Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Reported: November 11, 2020 Initiated: September 22, 2020 #Z-0319-2021
Product Description
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Reason for Recall
There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 8 devices
- Distribution
- Distributed in US - AR, FL, IL, and TX
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application. Recalled by Boston Scientific Corporation. Units affected: 8 devices.
Why was this product recalled? ▼
There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Moderate. Recall number: Z-0319-2021.
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