Boston Scientific ZOOM LATITUDE Pacemaker Programmer Software Displays Incorrect Diagnostic Dates
Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Class II device recall with no reported illnesses or injuries. The hazard involves diagnostic data corruption that could affect clinical decision-making, representing a risk-of-harm product without documented harm.
Plain-English summary
Boston Scientific Corporation is recalling the Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) devices installed with Model 2892 Programmer Application Software. These devices are used with several pacemaker models including ALTRUA, INSIGNIA I, and NEXUS I series devices.
The recalled software displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. This affects the diagnostic information displayed when monitoring these pacemakers.
Approximately 14,328 programmers have been distributed nationwide in the United States, including Guam, Puerto Rico, and the U.S. Virgin Islands, through government and military channels, and to over 70 countries internationally.
Patients and healthcare providers should contact Boston Scientific for updated software or guidance on managing their pacemakers during this recall.
The recalled product
- Product
- Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 14,328
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)
- All serial numbers. GTIN numbers in the U.S.: 00802526434723
- 00802526456961
- 00802526467653
- 00802526468582
- 00802526473449
- 00802526474859
- 00802526475788
- 00802526477676
- 00802526478239
- 00802526479663
- 00802526480638
- 00802526484599
- 00802526486906
- 00802526494406
- 00802526497605
- 00802526516009
- 00802526523212
- 00802526535406
- 00802526554209
- 00802526562600
Distribution
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