Device product
Innova 2000
Z-0904-2017
Product summary
- Event
- Event 75851
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total for all products 1,598 (USA 824, OUS 774)
- Official record key
device-enforcement:Z-0904-2017
Official wording
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.
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
Derived failure modes
-
Unknown
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.