Recall – Potential for PACS images to become corrupted

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

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