Z-2338-2020Class II

IntelliSpace PACS 4.4, Product number 837507 -

Name: Z-2338-2020 IntelliSpace PACS 4.4, Product number 837507 -
Creator: Philips Healthcare Informatics, Inc.
Published: 2019-04-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-04-19 / Completed / root cause: design

FDA source

Philips Healthcare Informatics, Inc. began a recall of IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and... on 2019-04-19. FDA classified it as Class II and gives the reason as "Images may potentially become corrupt while using the system". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-2338-2020
Classification: Class II
Status: Completed
Initiated: 2019-04-19
Posted: 2020-06-10
Recalling firm: Philips North America LLC
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Images may potentially become corrupt while using the system.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued a customer information letter beginning April 29, 2019, via FedEx (for the U.S. and Canadian customers) informing the consignee of the issue, their site was affected, and a time needed to be scheduled for an onsite visit.
Quantity in commerce: 26 units
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.
Product codes and lots: Product versions: 4.4.233.8 UDI N/A, 4.4.516.0 UDI N/A, 4.4.516.21 UDI N/A, 4.4.532.1 UDI N/A, 4.4.532.11 UDI N/A, 4.4.541.0 UDI N/A, 4.4.541.2 UDI (01)00884838074781(11)160825(10)4.4.541.2, 4.4.542.0 UDI (01)00884838074781(11)160822(10)4.4.542.0, 4.4.543.0 UDI (01)00884838074781(11)170131(10)4.4.543.0, 4.4.543.1 UDI (01)00884838074781(11)170321(10)4.4.543.1, 4.4.551.73 UDI (01)00884838074781(11)180907(10)4.4.551.73, 4.4.552.14 UDI (01)00884838074781(11)180509(10)4.4.552.14, and 4.4.552.18 UDI (01)00884838074781(11)181108(10)4.4.552.18.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2338-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2338-2020	Class II	Completed	Voluntary: Firm initiated	2020-06-17	2020-06-10

Product code LLZ

K111804Class IIIntellispace Pacs 4.XPhilips Healthcare Informatics, Inc. / cleared 2011-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)