Recall – Software error may lead to incorrect bolus delivery, Class I

Company: Smiths Medical ASD Inc.
Date of Enforcement Report: 8/12/2020
Class I

PRODUCT

CADD Medfusion Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Recall Number: Z-2734-2020

REASON

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

RECALLING FIRM/MANUFACTURER

Smiths Medical ASD Inc. on 6/26/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

35616 units

DISTRIBUTION

International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.