FDAFDA · Food and drugs·Recall number Z-0905-2017
ADVANTX LCA
Published January 4, 2017 · Recall initiated: November 21, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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
- Lot
- Mfg. Lot or Serial # System ID 00000048085YY5 706354SLCA 00000063506YY0 919443NGLCA Not Available 518761GLCA 00000052178YY1 914632LCA 00000052138YY5 740446LCA 00000063620YY9 843797LCA Not Available 414D1126 00000034252YY7 YX0950
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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