Volver al buscador
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

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta