CLASS II Device recall · Reported 20 Jun 2012 · FDA Enforcement Report

GE Healthcare Revolution XR/d recalled by General Electric Med Systems

General Electric Med Systems is recalling GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188. The recall was initiated on 31 May 2006 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall serial numbers

Quantity recalled3,796 units

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-1788-2012
FDA event ID: 37654
Recalling firm: General Electric Med Systems, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 31 May 2006
FDA classified: 8 Jun 2012
Reported: 20 Jun 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

31 May 2006	Recall initiated by company
8 Jun 2012	Classified by FDA	+2200 days
20 Jun 2012	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

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

Product as listed by the FDA

GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.

Where it was distributed

Worldwide Distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

all serial numbers

Where was it sold?

Worldwide Distribution.

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

2 other products · FDA event 37654

Reported	Class	Recall	Company	Reason	Where
20 Jun 2012	CLASS II	GE Healthcare Definium 8000 Digital Radiographic Systems recalled	General Electric Med Systems	Other	WI
20 Jun 2012	CLASS II	GE Proteus XR/a Radiographic System recalled	General Electric Med Systems	Other	WI

More recalls from General Electric Med Systems

All 3

Reported	Class	Recall	Company	Reason	Where
20 Jun 2012Device	CLASS II	GE Proteus XR/a Radiographic System recalled	General Electric Med Systems	Other	WI
20 Jun 2012Device	CLASS II	GE Healthcare Definium 8000 Digital Radiographic Systems recalled	General Electric Med Systems	Other	WI

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