FDA Device recall Z-2582-2024
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and…
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and… by Baxter Healthcare, citing 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 wh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2582-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-17 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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)
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.
Identifiers
| code_info | Pump UDI/DI GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2582-2024%22
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