Baxter SIGMA Spectrum Infusion Pump Software Anomaly Recall
Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library due to a software anomaly that may cause a Sharp Watchdog Timeout error.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source describes a software anomaly causing an error message without reporting specific injuries or hospitalizations, fitting the Moderate severity criteria for low-risk or theoretical hazards.
Plain-English summary
Baxter Healthcare Corporation is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library, Model #/Product Code 35700BAX2. The recall involves 14,175 units distributed domestically and 187 units in Canada. The affected units are identified by 14,362 serial numbers, which are available from the Center for Devices and Radiological Health (CDRH).
The recall is due to a software anomaly in Version 8.00.02 that may cause a 'Sharp Watchdog Timeout' error message. This error occurs specifically when a message is being written to the pump's Event History Log (EHL) and the length of that message exactly matches the size of the available memory at the end of a memory sector. The issue is more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.
Healthcare facilities and users should contact Baxter Healthcare Corporation or CDRH for specific instructions on how to proceed with the recall and to obtain the list of affected serial numbers.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
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 (2)
- 14
- 362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
Distribution
Distributed in 1 state:
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