# K010435: Philips BV Pulsera/Endura

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Mar 12, 2001 after 27 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
90 later devices descend from it; 3 cite it directly.
1 of 91 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032280: Siremobil Iso-C 3D (2003), 83 descendants of its own
- K050996: O-Arm Imaging System (2005), 52 descendants of its own
- K060344: O-Arm Imaging System (2006), 51 descendants of its own
- K081672: C-Insight (2008), 33 descendants of its own
- K102130: Tenzing System (2010), 31 descendants of its own

## Recalls of this device
- Oct 4, 2023 · Class II · Z-0224-2024: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance S
- Nov 12, 2021 · Class II · Z-0355-2022: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as r
- Nov 12, 2021 · Class II · Z-0356-2022: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as r
- Oct 4, 2011 · Not classified · Z-0118-2012: Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt
- Oct 4, 2011 · Not classified · Z-0116-2012: Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt
- Oct 4, 2011 · Not classified · Z-0117-2012: Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt
- Dec 14, 2010 · Not classified · Z-1604-2011: The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems.
- Dec 14, 2010 · Not classified · Z-1605-2011: The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems.
- Sep 10, 2008 · Not classified · Z-2463-2010: The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff
- Sep 10, 2008 · Not classified · Z-2464-2010: The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff
- Sep 5, 2008 · Not classified · Z-0140-2011: Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and image
- Sep 5, 2008 · Not classified · Z-0141-2011: Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and image

Source page: https://510kreport.com/device/K010435
Methodology: https://510kreport.com/methodology