Skip to content
Recall Observatory FDA recall evidence

Device product

Prestilix

Z-0914-2017

November 21, 2016

Class II

Product summary

Firm
GE Healthcare, LLC
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-0914-2017

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 Not Available 1301 Not Available 318783ARF Not Available 412488F1 Not Available AP3001XR10 Not Available 902567GI Not Available C4211004 00000048037YY6 PC7281XR02 Not Available PC0731XR01 Not Available A5816801 00000022153YY1 C5304806 00000023739YY6 PL1020RX01 Not Available RU1146RX01

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

    reason.no_named_rule · v1.0.0

    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.