Recall Z-0863-2024— Smiths Medical ASD Inc.

Name: FDA recall Z-0863-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-19

Class I · Ongoing

Class I FDA medical device recall by Smiths Medical ASD Inc., initiated 2023-12-19. It names one FDA 510(k) clearance: K040899. Product: smiths medical Medfusion Model 3500 Syringe pump. Reason: Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-12-19
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMPMedex, Inc.·cleared 2004-04-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

smiths medical Medfusion Model 3500 Syringe pump

Reason for recall

Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.

Data sourced from openFDA. This site is unofficial and independent of the FDA.