FDAClass IIJanuary 4, 2017

Advantx Lclp+ recall

ADVANTX LCLP+

Why was Advantx Lclp+ recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Mfg. Lot or Serial # System ID 00000047915YY4 415540ADVLCLP 00000063721YY5 909865LCLP Not Available 916734XR 00000063736YY3 MCTHKGMN 00000023830YY3 912633MCL1 00000023761YY0 912633MCL1 00000128484M03 312CCHGECATH 00000128484MO3 312CCHGECATH Not Available 507255CC101 Not Available LIJ015064 00000026160YY2 210428VCATH2 00000063805YY6 BPEP Not Available 414C4862 00000022150YY7 YX0738

Product
ADVANTX LCLP+
Recalling firm
GE Healthcare, LLC
Quantity
Total for all products 1,598 (USA 824, OUS 774)
Distribution
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
Recall date
January 4, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls