Philips Healthcare Informatics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2338-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 19, 2019

Date Posted: June 17, 2020

Recall Number: Z-2338-2020

Event ID: 85499

Reason for Recall:

Images may potentially become corrupt while using the system.

Status: Completed

Product Quantity: 26 units

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated