Company: Philips Healthcare Informatics, Inc.
Date of Enforcement Report: 6/17/2020
Class II

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.

Recall Number: Z-2338-2020

REASON

Images may potentially become corrupt while using the system.

RECALLING FIRM/MANUFACTURER

Philips Healthcare Informatics, Inc. on 4/19/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

26 units

DISTRIBUTION

U.S. Nationwide and International