Food, drugs, devices › Philips Healthcare Informatics, Inc.
Device recall: IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including bu
Philips Healthcare Informatics, Inc. (Pleasanton, CA) initiated this device recall on 19 Apr 2019; FDA lists 1 product record under event 85499, 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Completed. 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., Pleasanton, CA.
Reason for recall
"Images may potentially become corrupt while using the system."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2338-2020 | 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. | 26 units | Class II | Completed | 17 Jun 2020 |
Context
Other enforcement events for Philips Healthcare Informatics, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Jul 2014 | Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication | 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: "Images may potentially become corrupt while using the system."
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: "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…"
Is the recall still ongoing?
FDA lists the status as Completed. "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.