Philips Healthcare Informatics, Inc.
Philips Healthcare Informatics, Inc. appears in FDA public data with 4 recalls, 2 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2338-2020, Class II) was initiated on April 19, 2019. Its most recent 510(k) clearance was granted on December 6, 2018.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 2
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2338-2020 | Class II | IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained profess | April 19, 2019 |
| Z-2252-2014 | Class II | Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measuremen | July 24, 2014 |
| Z-1646-2014 | Class II | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiolog | May 5, 2014 |
| Z-0269-2014 | Class II | Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used | October 14, 2013 |