GE Medical Systems, LLC: GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.

Recall number

Z-0769-2016

Recalling firm

GE Medical Systems, LLC

Product

GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.

Status

Terminated

Initiated

2015-12-23

Posted

2016-02-08

Terminated

2016-09-07

Reason

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.

Root cause

Device Design

Action

Consignees were sent on 12/23/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 10906 dated December 18, 2015. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers may continue to use the system. The firm will correct the affected devices and no charge to the customer; and a GE Healthcare representative will contact customers to arrange for the correction. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Quantity

126

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

["K103476"]

PMA numbers

not on file

Product code

IZL

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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