FDA recall Z-2042-2023

Philips North America Llc · Class II · device

Product

DigitalDiagnost C90, Model No. 712034 and 712035

Reason for recall

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

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

Key facts

Status: Ongoing
Initiation date: 2023-05-19
Report date: 2023-07-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2042-2023