FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
- Recall number
- Z-0107-2019
- Recalling firm
- Baxter Healthcare Corporation
- Product
- SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
- Status
- Terminated
- Initiated
- 2018-09-18
- Posted
- not on file
- Terminated
- 2020-08-19
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 354 units
- Distribution
- NJ
- Lot, serial or model codes
- UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018
- 510(k) numbers
- ["K173084"]
- PMA numbers
- not on file
- Product code
- PHC
- Firm FEI
- 1314492
- Firm city
- Medina
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28