Revolution Xr/D Digital Radiographic Imaging System

510(k) K012389

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK012389	Date10 Aug 2001Cleared	StatusActive

4 recalls · FDA

- Terminated Z-1989-2014 FDA Class II initiated 4 Jun 2014
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.
- Terminated Z-0527-2010 FDA Unclassified (pre-2012) initiated 13 Aug 2009
Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction may occur, which could result in the tabletop brakes falling to engage when the control foot pedal is released to lock the floating tabletop in place.
- Terminated Z-1789-2012 FDA Class II initiated 31 May 2006 on shared 510(k) K012389
An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
- Terminated Z-0157-03 FDA Unclassified (pre-2012) initiated 21 Nov 2002 on shared 510(k) K012389
The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)