Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- November 23, 2020
- Recall Number
- Z-0715-2021
- Quantity
- 112,463 devices
- Firm Location
- Deerfield, IL
Reason for Recall
There is a potential software error during programming.
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Lot / Code Info
Product Code 3570009, GTIN 00085412610900
Root Cause
Under Investigation by firm
Action Taken
A Medical Device Correction communication will be sent to all affected customers via U.S.P.S., first class mail. All pumps will be updated with new software which will prevent the malfunction from occurring. The software upgrade will be implemented upon next service or a local Baxter service representative will contact the facility to determine the correction plan and schedule the software update.
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