# K911098: Philips Uro Diagnost MRF

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Jul 3, 1991 after 113 days
- Product code: IXR (Table, Radiographic, Tilting)
- Device class: 2
- Regulation: 21 CFR 892.1980
- Recalls of this device: 4 (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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 30, 2019 · Class II · Z-1492-2020: 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.
- Feb 28, 2019 · Class II · Z-1053-2019: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
- Mar 26, 2018 · Class II · Z-1604-2018: The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot 
- Jul 19, 2016 · Class II · Z-2306-2016: The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

Source page: https://510kreport.com/device/K911098
Methodology: https://510kreport.com/methodology