CLASS II Device recall · Reported 4 Jan 2017 · FDA Enforcement Report

Prestige VH recalled by GE Healthcare

GE Healthcare is recalling Prestige VH, distributed in 41 states. The recall was initiated on 21 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMfg. Lot or Serial # System ID Not Available 708425PREST 00000063646YY4 314525APR 00000034238YY6 910249LRF3 00000023833YY7 919472CGRFA 00000063653YY0 724284R4 00000052120YY3 713442KPDRS 00000063577YY1 509458DR10 00000048069YY9 AH4317XR04 00000052117YY9 AH3221XR06 00000026253YY5 AH5681XR02 Not Available CS1029RX01 00000113920MO3 EG1112RX05 00000023862YY6 M4159446 00000034208YY9 M4160037 Not Available M1875113 00000039660YY6 M4500608 00000048049YY1 M2880713 00000026209YY7 M4046528 Not Available M2838405 Not Available M2663805 00000089618MO3 M4202921 00000031488YY0 M9624214 00000023814YY7 M4496929 00000023829YY5 M4496929 Not Available B4192927 00000034269YY1 HC2834XR11 00000063668YY8 HC1627XR14 00000026202YY2 HC0393XR02 00000023796YY6 HC0760XR01 00000026216YY2 PC0545XR04 Not Available 490314XR02 Not Available MC5880XR03 Not Available CC2149XR02 Not Available IS1002RX01 00000063686YY0 IE1012RX03 00000063667YY0 IE1025RX02 Not Available IE1006RX07 00000063609YY2 A5250603 Not Available A5127805 00000034283YY2 NO1004RX01 00000026203YY0 NO1041RX01 Not Available NO1104RX01 00000048004YY6 NO1016RX02 00000080076YY3 PPR00132 00000063713YY2 PPR59013 00000026248YY5 RU1306RX01 00000063560YY7 CE165306 00000063616YY7 05074FLU02 00000063755YY3 38853103XRMET

Quantity recalledTotal for all products 1,598 (USA 824, OUS 774)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0913-2017
FDA event ID: 75851
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 21 Nov 2016
FDA classified: 23 Dec 2016
Reported: 4 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Nov 2016	Recall initiated by company
23 Dec 2016	Classified by FDA	+32 days
4 Jan 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Prestige VH

Where it was distributed

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

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

Which lots are affected?

Mfg. Lot or Serial # System ID Not Available 708425PREST 00000063646YY4 314525APR 00000034238YY6 910249LRF3 00000023833YY7 919472CGRFA 00000063653YY0 724284R4 00000052120YY3 713442KPDRS 00000063577YY1 509458DR10 00000048069YY9 AH4317XR04 00000052117YY9 AH3221XR06 00000026253YY5 AH5681XR02 Not Available CS1029RX01 00000113920MO3 EG1112RX05 00000023862YY6 M4159446 00000034208YY9 M4160037 Not Available M1875113 00000039660YY6 M4500608 00000048049YY1 M2880713 00000026209YY7 M4046528 Not Available M2838405 Not Available M2663805 00000089618MO3 M4202921 00000031488YY0 M9624214 00000023814YY7 M4496929 00000023829YY5 M4496929 Not Available B4192927 00000034269YY1 HC2834XR11 00000063668YY8 HC1627XR14 00000026202YY2 HC0393XR02 00000023796YY6 HC0760XR01 00000026216YY2 PC0545XR04 Not Available 490314XR02 Not Available MC5880XR03 Not Available CC2149XR02 Not Available IS1002RX01 00000063686YY0 IE1012RX03 00000063667YY0 IE1025RX02 Not Available IE1006RX07 00000063609YY2 A5250603 Not Available A5127805 00000034283YY2 NO1004RX01 00000026203YY0 NO1041RX01 Not Available NO1104RX01 00000048004YY6 NO1016RX02 00000080076YY3 PPR00132 00000063713YY2 PPR59013 00000026248YY5 RU1306RX01 00000063560YY7 CE165306 00000063616YY7 05074FLU02 00000063755YY3 38853103XRMET

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

12 other products · FDA event 75851

Reported	Class	Recall	Company	Reason	Where
4 Jan 2017	CLASS II	Precision 500D recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Advantx LCA recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Prestige SI recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Recalled product recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Advantx LCV+ recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Prestilix recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Innova recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Legacy recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Advantx Lclp+ recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Advantx LCN+ recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Recalled product recalled by GE Healthcare	GE Healthcare	Other	41 states
4 Jan 2017	CLASS II	Prestige II recalled by GE Healthcare	GE Healthcare	Other	41 states

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All 512

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