FDAFDA · Food and drugs·Recall number Z-0768-2016
GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Published February 17, 2016 · Recall initiated: December 23, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Medical Systems, LLC
- Distributor
- 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
- Lot or Serial numbers including but not limited to: 00001033715WK2, 12535HL3, 00000078321HL7, 00000096815HL6, 00000081147HL1, 00001032621WK3, 00000092076HL9, 00000092382HL1, 00000460115GE9, 00000079932HL0, D3s14793, 00000088642HL4, 116635HL4, 120632HL5, GEGR2411, GEGR5073, 00001027151WK8, 00000129105HL3, 261417HP0, 261416HP2, 1035189WK8, 00000084720HL2, 00000087109HL5, 00000100735HL0, 121206HL7, 125007HL5, 125019HL0, 1028231WK7, 00000126237HL7, 00000102072HL6, 00000092394HL6, 00000115802HL1, 124167HL8, 00001033721WK0, 00000108520HL8, 00000087928HL8, 00000111794HL4, 00000110657HL4, 00000092629HL5, 119090HL9, 00000442129GE3, 00000128179HL9, 00000110710HL1, 83621HL3, 00000082207HL2, 1034762WK3, 00000081499HL6, 00000088705HL9, 00000085601HL3, 00001031247WK8, 00000084721HL0, 00000084410HL0, 00000086179HL9, 1033866WK3, 00000084286HL4, 00000096817HL2, 00000092948HL9, 00000106841HL0, 00000105475HL8, 00001033220WK3, 00000106072HL2, 00000110662HL4, 00000106055HL7, 00000008789HL5, 00000084415HL9, 00000084713HL7, 00000091763HL3, 00000093367HL1, 123730HL4, 00000109436HL6, 00000078816HL6, 00000078490HL0, 120816HL4, 00000124501HL8, 00000124510HL9, 123456789, 00000095656BT5, 118267HL4, 00000081688HL4, 00000110668HL1, 123737HL9, 00000081500HL1, 00000084711HL1, 00000085596HL5, 00000118284HL9, 00000124201HL5, 00000118285HL6, 00000118462HL1, 00000118282HL3, 00000104908HL9, 00000102090HL8, 00000100174HL2, 120182HL1, D3S141084, 00000100430HL8, 00000097754HL6, 114137HL3, 00000099201HL6, 00000099204HL0, 00000111427HL1, 00000087073HL3, 120184HL7, 00000126701HL2, 00000128172HL4, 00000124478HL9, 00000124224HL7, 00000091044HL8, 00000107457HL4, 00000076792HL1, 00000112148HL2, 00001032707WK0, 00000101689HL8, 119104HL8, 00001027765WK5, 114191HL0, 00000085591HL6, 00001030627WK2, 00001030293WK3, 00001030654WK6, 00001030617WK3, GEGR3510, 119099HL0, 00000106829HL5, 120187HL0, 00000087076HL6, 00000124186HL8, 00000098182HL9, 120829HL7, 00000093383HL8, 124217HL1, 122883HL2, 121230HL7, 112145HL8, 00001033608WK9, 00000096582HL2, 121229hl9, 00000081796HL5, 00000404458GE2, 00000076912HL5, 00000080863HL4, 00000108423HL5, 00001030034WK1, 120159HL9, 00001029071WK6, 00000093374HL7, 00000087107HL9, 00001031749WK3, 00000091761HL7, 00000086996HL6, 00000092073HL6, 00001035466WK0, 133379BT8, 00001034661WK7, GEGR2475, 00000081817HL9, 00000124181HL9, 00000111919HL7, 00000109407HL7, 00000105795HL9, 00000106056HL5, 00000116630HL5, 00001027347WK2, 00000083537HL1, 00000086155HL9, 00000078491HL8, GEGR3252, 00000089859HL3, 00000096580HL6, 15B1433, 00000077251HL7, 00001031962WK2, 00001035186WK4, 00000081496HL2, 00000088645HL7, 00000080783HL4, 120808HL1, 00000087094HL9, 00000105455HL0, 00000119756HL5, 00001035456WK1, 00000083015HL8, 00000082740HL2, 00000084147HL8, 4123, 00000085042HL0, 00000087890HL0, 00001029042WK7, 00001031728WK7, 00000076403HL5, 00000092392HL0, 00000081819HL5, 00000125677HL5, 00000149748BT6, 00000101296HL2, 00000109423HL4, 00000108571HL1, 00000109425HL9, 00000090229HL6, 00000089140HL8, 00000085904HL1, 00000087922HL1, T600342, 00000093400HL0, 117199HL0, 00001033662WK6, 5331287-2, 113151hl5, 00000091758HL3, 00000095898HL3, UA46793-8, 00000100423HL3, 00000098211HL6, 1027422WK3, 116643HL8, 103908WK3, 00000110649HL1, 00000087077HL4, 00000084168HL4, 00000108418HL5, 108417hl7, 142904BT2, 116656HL0, 00000101693HL0, 00000122245HL4, 00001032825WX0, 1032825WK0, 00000081684HL3, 120678HL8, 00000078815HL8, 00000080777HL6, 00000080859HL2, 00000082462HL3, 00000083541HL3, 00000082725HL3, 00000082744HL4, 00000080633HL1, 00000085053HL7, 00000107167HL9, 00000092946HL3, 00000088702HL6, 00000089493HL1, 00000104904HL8, 118690HL7, 118689HL9, 122947HL5, 120655HL6, 121199HL4, 122031HL8, 120834HL7, 00000458240GE9, 124189HL2, 00000106047HL4, 00000120195HL3, 00000114150HL6, 124009HL2, 00000085913HL2, 119091hl7, 00000129120HL2, 00000129116HL0, 00000102997HL4, 00000101970HL2, 00000106076HL3, 00000079924HL7, 00000086169HL0, 00000124182HL7, 00000105457HL6, 00000098190HL2, 00000081813HL8, 0000008301
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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