CLASS II ONGOING Device recall · Reported 2 Oct 2019 · FDA Enforcement Report

Proteus XR/a (SlOK : K993090) recalled by GE Healthcare

GE Healthcare is recalling Proteus XR/a (SlOK : K993090), distributed nationwide in the US. The recall was initiated on 9 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesconsole part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)

Quantity recalled647 US; 167 OUS

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-2449-2019
FDA event ID: 83647
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 9 Aug 2019
FDA classified: 20 Sep 2019
Reported: 2 Oct 2019
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Aug 2019	Recall initiated by company
20 Sep 2019	Classified by FDA	+42 days
2 Oct 2019	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

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

Product as listed by the FDA

Proteus XR/a (SlOK : K993090)

Where it was distributed

Worldwide - US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

Which lots are affected?

console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)

Where was it sold?

Worldwide - US Nationwide

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.

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