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Recall Observatory FDA recall evidence

Device product

Prestige SI

Z-0912-2017

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-0912-2017

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 310665PREST 00000047974YY1 1711 Not Available 708799SPHR 00000026137YY0 708216L11 Not Available 219886NLP Not Available 504380LP3 00000031369YY2 201754PRES Not Available 718250RM2 00000031404YY7 330385FL6 Not Available 803464PRES 00000026140YY4 AP5821XR04 Not Available 519837REM Not Available 905565REM 00000031306YY4 514468BPRESTIGE 00000052130YY2 514468BPRESTIGE 00000034288YY1 514495PRESTIGE Not Available M9864607 Not Available M4261103 00000048089YY7 A5218915 00000047968YY3 PER18303

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.