# K971365: Philips Integris H5000

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: May 14, 1997 after 30 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K092713: Spectre Wireless Encrypted Footswitch and Hand Switch System (2010), 0 descendants of its own

## Recalls of this device
- Dec 30, 2019 · Class II · Z-1491-2020: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
- Nov 3, 2015 · Class II · Z-0718-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0719-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0721-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0730-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0717-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0720-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Feb 3, 2015 · Class II · Z-0347-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0349-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0354-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0353-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0348-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0350-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0351-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0352-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0346-2016: Monitor Ceiling Suspension system may fall
- Oct 10, 2003 · Not classified · Z-0099-04: The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories.

Source page: https://510kreport.com/device/K971365
Methodology: https://510kreport.com/methodology