Z-1693-2017 Class II Terminated
FDA device recall Z-1693-2017 was initiated by Baxter Healthcare Corporation on Jan 26, 2017 and is designated Class II. Reason for recall: SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the… The recall status is terminated (terminated May 24, 2018). Affected quantity: Domestic: 14,175 units; Canada: 187 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 5, 2017
- Initiation Date
- Jan 26, 2017
- Termination Date
- May 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 14,175 units; Canada: 187 units
Product description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Reason for recall
SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps 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. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.
Distribution pattern
Natiowide, Puerto Rico and Canada
Code information
14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1693-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026