FDA Medical Device Recalls (openFDA)
Philips Healthcare Informatics, Inc.: 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
- Recalling firm
- Philips Healthcare Informatics, Inc.
- 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.
- Status
- Completed
- Initiated
- 2019-04-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Images may potentially become corrupt while using the system.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K111804"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3002971142
- Firm city
- Pleasanton
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28