Recall Z-0911-2017— GE Healthcare, LLC

Name: FDA recall Z-0911-2017
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: K943805. Product: Prestige II. 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

K943805 — PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHDGeneral Electric Co.·cleared 1994-09-23

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

Prestige II

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.