Recall Z-2338-2020— Philips Healthcare Informatics, Inc.

Name: FDA recall Z-2338-2020
Creator: U.S. Food and Drug Administration
Published: 2019-04-19

Class II · Completed

Class II FDA medical device recall by Philips Healthcare Informatics, Inc., initiated 2019-04-19. It names one FDA 510(k) clearance: K111804. 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: Images may potentially become corrupt while using the system..

Recalling firm: Philips Healthcare Informatics, Inc.
Classification: Class II
Status: Completed
Initiated: 2019-04-19
Firm location: Pleasanton, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K111804 — INTELLISPACE PACS 4.XPhilips Healthcare Informatics, Inc.·cleared 2011-07-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.