Device product
Baxter Electrocardiograph, ELI 380 -DCS21
Z-1013-2023
Product summary
- Event
- Event 91388
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1013-2023
Official wording
Reason: One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
Code information: Lot number 122420001706
Distribution pattern: TX
Derived failure modes
-
Unknown
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.