Device product
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
Z-2582-2024
Product summary
- Event
- Event 94988
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,377 units
- Official record key
device-enforcement:Z-2582-2024
Official wording
Reason: The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
Code information: Pump UDI/DI GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30
Distribution pattern: US, Nationwide
Derived failure modes
-
Device software or design
software issue