# K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Feb 25, 1999 after 65 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.
266 later devices descend from it; 8 cite it directly.
10 of 267 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 its predicate without a number.
- (no number) Philips Integris V5000: named in the summary without a submission number
- (no number) Philips Integris H5000: named in the summary without a submission number

## Most influential descendants
- K042961: Spy Intra-Operative Imaging System: SP2000 (2005), 136 descendants of its own
- K060867: Spy Intraoperative Imaging System (2006), 134 descendants of its own
- K061871: Leica Model FL800 (2006), 133 descendants of its own
- K071037: Spy Intra-Operative Imaging System, Model SP2000 (2007), 131 descendants of its own
- K063345: Spy Imaging System (2007), 131 descendants of its own

## Recalls of this device
- Feb 19, 2019 · Class II · Z-1140-2019: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This
- Feb 19, 2019 · Class II · Z-1141-2019: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This
- Sep 24, 2014 · Class II · Z-1280-2016: Loss of key image functionality due to a bent pedal of the Footswitch.
- Oct 7, 2010 · Not classified · Z-1655-2011: A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.
- Feb 4, 2010 · Not classified · Z-2449-2010: A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem can only resolved by a warm or cold system restart. In exceptional cases the power converter
- Feb 4, 2010 · Not classified · Z-2448-2010: A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could only resolved by a warm or cold system restart. In exceptional cases the power convert
- Dec 10, 2008 · Not classified · Z-0344-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Dec 10, 2008 · Not classified · Z-0345-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Dec 10, 2008 · Not classified · Z-0346-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Dec 10, 2008 · Not classified · Z-0348-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Oct 23, 2008 · Not classified · Z-2475-2010: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and henc
- Oct 23, 2008 · Not classified · Z-2471-2010: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and henc
- Oct 23, 2008 · Not classified · Z-2473-2010: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and henc
- Oct 23, 2008 · Not classified · Z-2472-2010: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and henc
- Dec 14, 2006 · Not classified · Z-0367-2007: Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Oct 12, 2005 · Not classified · Z-0206-06: Potential for high voltage exposure involving the injector interface connector of patient support tables.
- Oct 12, 2005 · Not classified · Z-0207-06: Potential for high voltage exposure involving the injector interface connector of patient support tables.

## Indications for use
The Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.

Source page: https://510kreport.com/device/K984545
Methodology: https://510kreport.com/methodology