Spectrum Wireless Battery Modules A/B/G/N recall: Software Issue
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009…
Why was Spectrum Wireless Battery Modules A/B/G/N recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Pump UDI/DI GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30
- 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…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 17,377 units
- Distribution
- US, Nationwide
- Recall date
- August 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)