Device product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Z-0712-2021
Product summary
- Event
- Event 86758
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9,353 devices
- Official record key
device-enforcement:Z-0712-2021
Official wording
Reason: There is a potential software error during programming.
Code information: Product Code 35700ABB, GTIN 00085412091570
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Derived failure modes
-
Device software or design
software error