Food, drugs, devices › Philips Healthcare Informatics, Inc.
Device recall: Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication
Philips Healthcare Informatics, Inc. (Foster City, CA) initiated this device recall on 24 Jul 2014; FDA lists 1 product record under event 68979, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 11 Feb 2016. Initiation: voluntary: firm initiated. Philips Healthcare Informatics, Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Healthcare Informatics, Inc., Foster City, CA.
Reason for recall
"A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data."
Distribution
"US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2252-2014 | Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. | 109 units | Class II | Terminated | 27 Aug 2014 |
Context
Other enforcement events for Philips Healthcare Informatics, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Apr 2019 | IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including bu | Device | Class II | 1 |
| 5 May 2014 | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (R | Device | Class II | 1 |
| 14 Oct 2013 | Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose | Device | Class II | 1 |
All 4 events for Philips Healthcare Informatics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Feb 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.