IntelliSpace PACS 4.4, Product number 837507 - Product… recallZ-2338-2020 · Philips Healthcare Informatics, Inc. · initiated Apr 19, 2019
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Healthcare Informatics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Images may potentially become corrupt while using the system.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2338-2020
- Status
- Completed
- Initiated by the company
- Apr 19, 2019
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Quantity
- 26 units
- Product code
- LLZ
- FDA submissions
- K111804
- 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 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.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IntelliSpace PACS IntelliSpace PACS - 4Philips Healthcare Informatics, Inc. · System, image processing, radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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