GE Healthcare, LLC: Medical Device Recall in 2017 - (Recall #: Z-0904-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Innova 2000

Product Classification:

Class II

Date Initiated: November 21, 2016

Date Posted: January 4, 2017

Recall Number: Z-0904-2017

Event ID: 75851

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.

Status: Terminated

Product Quantity: Total for all products 1,598 (USA 824, OUS 774)

Code Information:

Mfg. Lot or Serial # System ID 00000063779YY3 303320CL2 00000063791YY8 312792RINOV2 00000128531M05 973365LAB1 00000063734YY8 312792GEMNET

Distribution Pattern:

US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated