# K964712: Prism XPVT System (210823)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 21, 1997 after 88 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Mar 6, 2015 · Class II · Z-1775-2015: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overh
- Nov 18, 2011 · Not classified · Z-0988-2012: Philips was informed that the detector buckets may experience weakness over time. As a result, this could cause the detector bucket to separate from the mounting plate of the gantry and eventually res
- Nov 21, 2007 · Not classified · Z-1511-2008: Resistor Failure: The Rotate Motion Shunt Resistor may overheat and results in the appearance of smoke, a burning smell, and an electronic stop condition, which will disable the gamma camera rotate mo
- Nov 21, 2007 · Not classified · Z-1510-2008: Resistor Failure: The Rotate Motion Shunt Resistor may overheat and results in the appearance of smoke, a burning smell, and an electronic stop condition, which will disable the gamma camera rotate mo
- Nov 21, 2007 · Not classified · Z-1512-8: Resistor Failure: The Rotate Motion Shunt Resistor may overheat and results in the appearance of smoke, a burning smell, and an electronic stop condition, which will disable the gamma camera rotate mo
- Sep 15, 2003 · Not classified · Z-0093-04: Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.

## Indications for use
The Prism XPVT system is intended to be used for diagnostic imaging of organs and lesions.

Source page: https://510kreport.com/device/K964712
Methodology: https://510kreport.com/methodology