Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall GE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall GE see related information
Date Initiated by Firm December 19, 2022
Date Posted February 08, 2023
Recall Status1 Open3, Classified
Recall Number Z-1057-2023
Recall Event ID 91456
510(K)Number K153402  
Product Classification System, tomography, computed, emission - Product Code KPS
Product 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
Code Information 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
Recalling Firm/
Manufacturer		 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
4, Hayozma St
Tirat Carmel Israel
For Additional Information Contact GE HealthCare Service
800-4371171
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION on 12/19/2022 by mail. The notice explained the issue and the risk, and requested the following action by taken: .GE Healthcare asks that you STOP USE of your Nuclear Medicine system, if your system is listed in the Affected Product Details and Appendix of this letter, until an inspection of your system is completed by GE Healthcare and you have been provided with a letter indicating the system can be returned to clinical use. .GE Healthcare will correct all affected products at no cost to you. GE Healthcare will inspect your system to ensure that the appropriate mitigation is correctly implemented to address this potential life-threatening concern. A GE Healthcare representative will contact you to arrange for this correction. .If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 86 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE HEALTHCARE
-
-