FDA recall Z-2338-2020

Philips Healthcare Informatics, Inc. · Class II · device

Product

IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

Reason for recall

Images may potentially become corrupt while using the system.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, LA, MA, MI, MO, NC, NH, NY, OR, and TX. There was government distribution but no military distribution. The countries of Canada, Brazil, Ireland, New Zealand, United Arab Emirates, and the United Kingdom.

Key facts

Status
Completed
Initiation date
2019-04-19
Report date
2020-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pleasanton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2338-2020