FDAFDA · Alimentos y medicamentos·N.º oficial Z-0768-2016
GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Publicado el 17 de febrero de 2016 · Inicio del retiro: 23 de diciembre de 2015
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Medical Systems, LLC
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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