Baxter Infusion Pump Recall: SIGMA Spectrum V6 Software Defect
Baxter Healthcare recalls 14 SIGMA Spectrum Infusion Pump V6 units due to incorrect software version. The recalled units were distributed to 10 US states.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates reasonable probability of serious adverse health consequences. Although no injuries or illnesses have been reported, regulatory classification as Class I mandates Severe severity per the rubric.
Plain-English summary
Baxter Healthcare Corporation has recalled 14 SIGMA Spectrum Infusion Pump V6 units (Model 35700BAX) because certain units contain an incorrect software version.
These infusion pumps are medical devices used to deliver medications. The affected units were distributed to healthcare facilities in California, Florida, Illinois, Kansas, Michigan, Mississippi, New York, Ohio, Oklahoma, and Virginia.
Specific serial numbers affected include: 765100, 772744, 789742, 841197, 867753, 920606, 1024015, 770164, 788724, 793079, 842498, 918342, 962810, and 1027523. The FDA classified this as a Class I recall, indicating the defect may cause serious adverse health consequences.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- software-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- UDI-DI: 00085412091570
- Serial Numbers: 765100
- 772744
- 789742
- 841197
- 867753
- 920606
- 1024015 770164 788724
- 793079
- 842498
- 918342
- 962810
- 1027523
Distribution
Distributed in 10 states:
- CA
- FL
- IL
- KS
- MI
- MS
- NY
- OH
- OK
- VA
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