The Recall Desk
HighFDA (Devices)·Z-1670-2022·Announced 2022-09-07

ZOOM LATITUDE Programmer Recalled for Potential Software Communication Anomalies

Boston Scientific recalled the ZOOM LATITUDE Programmer (Model 2868) for potential software anomalies affecting communication with certain transvenous defibrillators. No injuries have been reported. The recall involves 17,172 units distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for potential software anomalies in a high-risk defibrillator programmer device. The hazard is described as theoretical ('potential') with no reported injuries or illnesses. Per the rubric, risk-of-harm products where no injury has been reported score at most 3 (High).

Plain-English summary

The ZOOM LATITUDE Programmer, specifically the Model 2868 Application software, is used to control all communication functions between a programming device and Boston Scientific implantable pulse generators (defibrillators). This recall affects 17,172 units distributed worldwide.

The FDA classified this as a Class II recall due to potential for unanticipated software anomalies that may occur when the Model 2868 Application software is loaded on the 3120 ZOOM LATITUDE programmer and is used to communicate with certain Boston Scientific transvenous defibrillators. No deaths, injuries, or illnesses have been reported.

Patients with implanted defibrillators and clinical staff who use the ZOOM LATITUDE Programmer may be affected if they possess equipment matching the affected serial numbers provided by the FDA. Healthcare facilities should verify whether they have affected units by cross-referencing the product serial numbers listed in the official FDA recall notice. Affected equipment is identified by specific UPN codes and serial number ranges.

The recalled product

Product
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.
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Defibrillator Programmer
Hazard
Affected units
17,172

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UPN: 00802526434723
  • Serial Numbers: 051026
  • 051075
  • 051091
  • 051121
  • 051146
  • 051156
  • 051171
  • 051182
  • 051207
  • 051232
  • 051236
  • 051239
  • 051270
  • 051320
  • 051335
  • 051358
  • 051367
  • 051370
  • 051374

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Boston Scientific Corporation

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Same hazard · software anomaly

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