CLASS II Device recall · Reported 17 Feb 2016 · FDA Enforcement Report

GE Healthcare, Brivo XR285amx Mobile Digital Ready recalled

GE Medical Systems is recalling GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to, distributed in District of Columbia, Puerto Rico. The recall was initiated on 23 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot or serial numbers include but not limited to: 00000086177HL3, 00001028564WK1, 115226HL3, 00000083538HL9, 00000092940HL6, 00000084909HL1, 00000081798HL1, 120634HL1, 00000084729HL3, 00000084161HL9, 00000082463HL1, 00000080868HL3, 120832HL1, 00000089868HL4, 00000082736HL0, 00000093379HL6, 00000092616HL2, 00000092633HL7, 00000081160HL4, 00000077253HL3, 00000076913HL3, 00000078498HL3, 00000084160HL1, 00000078315HL9, 00000082726HL1, 00000085039HL6, 00000080635HL6, 00000091403HL6, 00000085598HL1, 00000085661HL7, 00000077923HL1, 00000081481HL4, 00001027046WK0, 00000081152HL1, 00000086364HL7, 00000092622HL0, 00000085000HL8, 00000084999HL2, 00000084725HL1, 00000083029HL9, 00000078313HL4, 00000084162HL7, 00000083020HL8, 00000077471HL1, 00000083019HL0, 00000082738HL6, 00000083598HL3, 00000092618HL8, 00000084180HL9, 00000085594HL0, 00000084917HL4, 00000076790HL5, 00000091413HL5, 00001028931WK2, 00000102856WK4, 00001028927WK0, 00001028924WK7, 00000084159HL3, 00000084422HL5, 00001029525WK1, 00000077482HL8, 00000082250HL2, 00000075962HL1, 00000079632HL6, 00000082240HL3, 00000081484HL8, 00000084732HL7, 00000077924HL9, 00000079918HL9, 00000082247HL8, 00000082245HL2, 00000082243HL7, 00000077255HL8, 00000086373HL8, 00000087093HL1, 00000102539HL4, 00000085004HL0, 00000085599HL9, 00000079559HL1, 00000079282HL0, 00000077782HL1, 00000082480HL5, 00000079116HL0, 00001028894WK2, 00000078317HL5, 00000079280HL4, 00000129740WG7, 00000079278HL8, 00000078492HL6, 00000075947HL2, 00000084908KL3, 00000084412HL6, 00000084169HL2, 00001027692WK1, 00000085036HL2, 0000000012C559, 00000084178HL3, 00000093852HL2, 00000092058HL7, 00000087079HL0, 00001029020WK3, 00001028888WK4, 00001028659WK9, 00001028662WK3, 00001028661WK5, 00000086380HL3, 00001028660WK7, 00000084172HL6, 00001028595WK5, 00000086365HL4, 00000084411HL8, 00000084402HL7, 00000084906HL7, 00001028866WK0, 00001028925WK4, and 00000085034HL7.

Quantity recalled126

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-0769-2016
FDA event ID: 72974
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 23 Dec 2015
FDA classified: 9 Feb 2016
Reported: 17 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

23 Dec 2015	Recall initiated by company
9 Feb 2016	Classified by FDA	+48 days
17 Feb 2016	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

Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

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 XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.

Where it was distributed

Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Lebanon, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad , Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

District of Columbia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot or serial numbers include but not limited to: 00000086177HL3, 00001028564WK1, 115226HL3, 00000083538HL9, 00000092940HL6, 00000084909HL1, 00000081798HL1, 120634HL1, 00000084729HL3, 00000084161HL9, 00000082463HL1, 00000080868HL3, 120832HL1, 00000089868HL4, 00000082736HL0, 00000093379HL6, 00000092616HL2, 00000092633HL7, 00000081160HL4, 00000077253HL3, 00000076913HL3, 00000078498HL3, 00000084160HL1, 00000078315HL9, 00000082726HL1, 00000085039HL6, 00000080635HL6, 00000091403HL6, 00000085598HL1, 00000085661HL7, 00000077923HL1, 00000081481HL4, 00001027046WK0, 00000081152HL1, 00000086364HL7, 00000092622HL0, 00000085000HL8, 00000084999HL2, 00000084725HL1, 00000083029HL9, 00000078313HL4, 00000084162HL7, 00000083020HL8, 00000077471HL1, 00000083019HL0, 00000082738HL6, 00000083598HL3, 00000092618HL8, 00000084180HL9, 00000085594HL0, 00000084917HL4, 00000076790HL5, 00000091413HL5, 00001028931WK2, 00000102856WK4, 00001028927WK0, 00001028924WK7, 00000084159HL3, 00000084422HL5, 00001029525WK1, 00000077482HL8, 00000082250HL2, 00000075962HL1, 00000079632HL6, 00000082240HL3, 00000081484HL8, 00000084732HL7, 00000077924HL9, 00000079918HL9, 00000082247HL8, 00000082245HL2, 00000082243HL7, 00000077255HL8, 00000086373HL8, 00000087093HL1, 00000102539HL4, 00000085004HL0, 00000085599HL9, 00000079559HL1, 00000079282HL0, 00000077782HL1, 00000082480HL5, 00000079116HL0, 00001028894WK2, 00000078317HL5, 00000079280HL4, 00000129740WG7, 00000079278HL8, 00000078492HL6, 00000075947HL2, 00000084908KL3, 00000084412HL6, 00000084169HL2, 00001027692WK1, 00000085036HL2, 0000000012C559, 00000084178HL3, 00000093852HL2, 00000092058HL7, 00000087079HL0, 00001029020WK3, 00001028888WK4, 00001028659WK9, 00001028662WK3, 00001028661WK5, 00000086380HL3, 00001028660WK7, 00000084172HL6, 00001028595WK5, 00000086365HL4, 00000084411HL8, 00000084402HL7, 00000084906HL7, 00001028866WK0, 00001028925WK4, and 00000085034HL7.

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

2 other products · FDA event 72974

This product is part of a recall event; the main page for the event is GE Healthcare, Optima XR220amx recalled by GE Medical Systems.

Reported	Class	Recall	Company	Reason	Where
17 Feb 2016	CLASS II	GE Healthcare, Optima XR220amx recalled by GE Medical Systems	GE Medical Systems	Device Malfunction	DC, PR
17 Feb 2016	CLASS II	GE Healthcare, Optima XR200amx recalled by GE Medical Systems	GE Medical Systems	Device Malfunction	DC, PR

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