CLASS II Device recall · Reported 6 Mar 2013 · FDA Enforcement Report

Brivo XR385 DR-F/ X-Ray System X-Ray System recalled by GE Healthcare

GE Healthcare is recalling Brivo XR385 DR-F/ X-Ray System X-Ray System, distributed nationwide in the US. The recall was initiated on 3 Aug 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number : 5271997

Quantity recalled9 units installed in US

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-0761-2013
FDA event ID: 64226
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 3 Aug 2012
FDA classified: 26 Feb 2013
Reported: 6 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

3 Aug 2012	Recall initiated by company
26 Feb 2013	Classified by FDA	+207 days
6 Mar 2013	Published in enforcement report	+8 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 has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System

Where it was distributed

Nationwide Distribution including NM, WY, FL, MO, MA, and MI.

Nationwide Florida Massachusetts Michigan Missouri New Mexico Wyoming

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number : 5271997

Where was it sold?

Nationwide Distribution including NM, WY, FL, MO, MA, and MI.

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.

More recalls from GE Healthcare

All 512

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Signa Premier systems recalled by GE Healthcare	GE Healthcare	Other	Nationwide
11 Mar 2026Device	CLASS II	Centricity Universal Viewer Zero Footprint Client recalled	GE Healthcare	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS II	GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled	GE Healthcare	Device Malfunction
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

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay