Recall Z-0906-2017— GE Healthcare, LLC

Name: FDA recall Z-0906-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-21

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2016-11-21, terminated 2017-09-26. It names one FDA 510(k) clearance: K974367. Product: ADVANTX LCLP+. Reason: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Terminated: 2017-09-26
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K974367 — ADVANTX LCN, ADVANTX LCLPGE Medical Systems·cleared 1998-02-13

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

ADVANTX LCLP+

Reason for recall

GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.

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