Z-2110-2021 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 4, 2021
- Termination Date
- September 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130135 units
Product Description
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Reason for Recall
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
Distribution Pattern
United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.
Code Information
All Serial Numbers