The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
Reported: September 7, 2022 Initiated: July 7, 2022 #Z-1671-2022
Product Description
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
Reason for Recall
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 17,172 units in total
- Distribution
- Worldwide Distribution
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.. Recalled by Boston Scientific Corporation. Units affected: 17,172 units in total.
Why was this product recalled? ▼
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1671-2022.
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