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

Recalled product recalled by GE Healthcare

GE Healthcare is recalling Recalled product, 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 00000119847MO2 205345RF2 Not Available 501239AMR3 00000063563YY1 602588OP1 Not Available 805326KM3 00000031477YY3 619725RM2 00000031386YY6 619725RM6 Not Available 707263LXR2 Not Available 209578AVTX 00000034272YY5 805497RM7 00000031317YY1 916555RF1 00000039665YY5 415750S9 00000026124YY8 415565DFL2 00000063453YY5 714985R3 Not Available 813932SPEC 00000023723YY0 229312DRS Not Available 404589GSF 00000026193YY3 404791D4A 00000063484YY0 319652ADVRF Not Available 618549CMRF1 00000023674YY5 317662RM4 Not Available 317662RM3 Not Available 812232ARM2 00000023719YY8 502746RF Not Available 318948DRS Not Available 301891RM1 Not Available 410337RF 00000023681YY0 313493ADV 00000023705YY7 517334ADV 00000022193YY7 612243RF 00000031310YY6 816276BRF1 Not Available 704342NR5 Not Available 704765RF1 00000022177YY0 201858RM3 00000022171YY3 505887GRF1 00000022159YY8 505392RF2 Not Available 516579R2 00000052108YY8 718739RF 00000023699YY2 212844RM3 00000031337YY9 405323CRF 00000039657YY2 215831SP Not Available 803522B2 00000052115YY3 803899RF1 00000023744YY6 423926RF Not Available 409883BRF 00000023676YY0 817735FP2 00000026181YY8 703783ARF4 Not Available 703459RF1 00000026111YY5 414529RF1 Not Available 414D1183 00000023843YY6 304348MX8 00000022190YY3 304647GX1 00000022132YY5 00658FLU01

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-0916-2017
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

SFX

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 00000119847MO2 205345RF2 Not Available 501239AMR3 00000063563YY1 602588OP1 Not Available 805326KM3 00000031477YY3 619725RM2 00000031386YY6 619725RM6 Not Available 707263LXR2 Not Available 209578AVTX 00000034272YY5 805497RM7 00000031317YY1 916555RF1 00000039665YY5 415750S9 00000026124YY8 415565DFL2 00000063453YY5 714985R3 Not Available 813932SPEC 00000023723YY0 229312DRS Not Available 404589GSF 00000026193YY3 404791D4A 00000063484YY0 319652ADVRF Not Available 618549CMRF1 00000023674YY5 317662RM4 Not Available 317662RM3 Not Available 812232ARM2 00000023719YY8 502746RF Not Available 318948DRS Not Available 301891RM1 Not Available 410337RF 00000023681YY0 313493ADV 00000023705YY7 517334ADV 00000022193YY7 612243RF 00000031310YY6 816276BRF1 Not Available 704342NR5 Not Available 704765RF1 00000022177YY0 201858RM3 00000022171YY3 505887GRF1 00000022159YY8 505392RF2 Not Available 516579R2 00000052108YY8 718739RF 00000023699YY2 212844RM3 00000031337YY9 405323CRF 00000039657YY2 215831SP Not Available 803522B2 00000052115YY3 803899RF1 00000023744YY6 423926RF Not Available 409883BRF 00000023676YY0 817735FP2 00000026181YY8 703783ARF4 Not Available 703459RF1 00000026111YY5 414529RF1 Not Available 414D1183 00000023843YY6 304348MX8 00000022190YY3 304647GX1 00000022132YY5 00658FLU01

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

This product is part of a recall event; the main page for the event is Prestige VH recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
4 Jan 2017	CLASS II	Prestige VH recalled by GE Healthcare	GE Healthcare	Other	41 states
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	Prestige II recalled by GE Healthcare	GE Healthcare	Other	41 states

More recalls from GE Healthcare

All 512

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9 Apr 2025Device	CLASS II	Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare	GE Healthcare	Other	IL
9 Apr 2025Device	CLASS II	Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare	GE Healthcare	Other	IL

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