FDA Device Recall Z-1057-2023

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System

Lot / serial / GTIN: a) 870 CZT O540+ Gantry 7.25mm: Catalog number H3906CW , UDI/DI 01008406821408432187CZ6304211200300, Serial Numbers: 87CZ63042; UDI/DI 01008406821408432187CA6305311210100, Serial Numbers: 87CA63053; UDI/DI 01008406821408432187CX6301111181000, Serial Numbers: 87CX63011; UDI/DI 01008406821408432187CY6302011190300, Serial Numbers: 87CY63020; UDI/DI 01008406821408432187CY6303511191100, Serial Numbers: 87CY63035; UDI/DI 01008406821408432187CZ6304011200100, Serial Numbers: 87CZ63040; UDI/DI 01008406821408432187CX6300411180700, Serial Numbers: 87CX63004; UDI/DI 01008406821408432187CX6300911180900, Serial Numbers: 87CX63009; UDI/DI 01008406821408432187CB6307211220700, Serial Numbers: 87CB63072; UDI/DI 01008406821408432187CA6306111211100, Serial Numbers: 87CA63061; UDI/DI 01008406821408432187CY6303211191000, Serial Numbers: 87CY63032; UDI/DI To be provided, Serial Numbers: 87CB63075, 87CA63058, 87CB63070, 87CB63069, 87CB63071, 87CB63077, 87CA63063, 87CB63064, 87CB63078, 87CA63062, 87CB63067, 87CA63057, 87CA63060, 87CB63065, 87CB63068, 87CB63074; UDI/DI Not Applicable, Serial Numbers: 87CY63019, 87CA63054, 87CZ63043, 87CA63055, 87CY63028, 87CY63037, 87CZ63044, 87CZ63045, 87CZ63048, 87CZ63041, 87CY63024, 87CY63017, 87CX63007, 87CX63008, 87CX63006, 87CX63014, 87CY63022, 87CX63015, 87CY63025, 87CX63010, 87CZ63052, 87CY63027, 87CY63026, 87CY63030, 87CZ63046, 87CX63013, 87CY63036, 87CZ63047, 87CY63033, 87CY63016, 87CX63005, 87CZ63039, 87CX63002, 87CX63012, 87CX63001, 87CY63023, 87CY63018; b) D670 CZT Gantry 7.25mm: Catalog number H3906DD, UDI/DI Not Applicable, Serial Numbers: CZGA55003, CZGA55004, CZGY55001; , UDI/DI To be provided, Serial Numbers: CZGB55006, CZGA55005, CZGB55007; c) DISCOV NM/CT 870 CZT: Catalog number H3906CW, UDI/DI 01008406821408432187CY6303811191200, Serial Numbers: 87CY63038; d) Discovery NMCT 670 CZT O540+: Catalog number H3906DD , UDI/DI Not Applicable, Serial Numbers: CZGZ55002; e) NM/CT 870 CZT CYBER DEFENCE: Catalog number H3906FK, UDI/DI To be provided, Serial Numbers: 87DB82001; f) NM/CT 870 CZT O540: Catalog number H3906CW , UDI/DI Not Applicable, Serial Numbers: 87CY63021, 87CZ63050, 87CZ63049, 87CZ63051, 87CY63034; g) NM/CT 870 CZT WSO: Catalog number 5376204-70-20, UDI/DI 01008406821408432187CA6305911210800, Serial Numbers: 87CA63059; UDI/DI 01008406821408432187CB6307611221000, Serial Numbers: 87CB63076; UDI/DI 01008406821408432187CB6307311220800, Serial Numbers: 87CB63073; : Catalog number H3906CW, UDI/DI To be provided, Serial Numbers: 87CB63066; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 87CA63056; h) NM/CT 870 CZT: Catalog number H3906CW, UDI/DI Not Applicable, Serial Numbers: 87CY63031; i) NM/CT 870 CZT O540+ 7.25MM: Catalog number H3906CV, UDI/DI 01008406821408432187CX6300311180700, Serial Numbers: 87CX63003; UDI/DI 01008406821408432187CY6302911190800, Serial Numbers: 87CY63029

Quantity: 86 units

Reason for recall

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Recall record

Recall number: Z-1057-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.
Recall initiated: 2022-12-19
Classified by FDA Center: 2023-02-08
FDA published: 2023-02-15
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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