FDA Recall: Software Issue Prevents Users from Logging In

Company: Philips North America Llc
Date of Enforcement Report: 06/29/2023
Class II

PRODUCT

DigitalDiagnost C90, Model No. 712034 and 712035

Recall Number:

Z-2042-2023

REASON:

There is a software login in issue that may prevent the user from logging in.

RECALLING FIRM/MANUFACTURER:

Philips North America Llc

VOLUME OF PRODUCT IN COMMERCE:

58

DISTRIBUTION:

Distribution in US: AZ, GA, IN, IA, MN, NE, NH, OH, TX OUS distribution to Australia, Chile, China, Malta, Namibia, New Zealand, Oman, Panama, Qatar, Suriname, United Kingdom

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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