SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
This recall has been terminated (originally issued September 18, 2018).
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- September 18, 2018
- Terminated
- August 19, 2020
- Recall Number
- Z-0107-2019
- Quantity
- 354 units
- Firm Location
- Medina, NY
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
NJ
Lot / Code Info
UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018
Root Cause
Software design
Action Taken
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.
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