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

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

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Corporate Office

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