Spectrum Iq Infusion System With Dose Iq Safety Software… recallZ-0107-2019 · Baxter Healthcare Corporation · initiated Sep 18, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.
FDA root cause category: Software design
What the company is doing
The firm initiated their field correction by email on 09/14/2018. The notice alerted the consignee of the problem and stated that Baxter would be issuing a software update to correct the issue.
Recall details
- Recall number
- Z-0107-2019
- Status
- Terminated
- Initiated by the company
- Sep 18, 2018
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 354 units
- Product code
- PHC
- FDA submissions
- K173084
- Distribution
- NJ
Product description
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Code information (models, lots, serial numbers)
UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Spectrum IQ 3570009Baxter Healthcare Corporation · Infusion safety management software11 recalls10 deaths9,086 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page