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Recall Observatory FDA recall evidence

Device product

Precision 500D

Z-0910-2017

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-0910-2017

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 00000034206YY3 229353TR2 00000146304MO1 423778ERM4 Not Available 817255NHPD1

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.