Recall Z-2449-2019— GE Healthcare, LLC

Name: FDA recall Z-2449-2019
Creator: U.S. Food and Drug Administration
Published: 2019-08-09

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-08-09. It names one FDA 510(k) clearance: K993090. Product: Proteus XR/a (SlOK : K993090). Reason: Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-08-09
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K993090 — SILHOUETTE FCGe Medical Systems, Inc.·cleared 1999-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Proteus XR/a (SlOK : K993090)

Reason for recall

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.