Class 2 Device Recall GE Healthcare Infinia

• Date Initiated by Firm: December 18, 2024
• Date Posted: January 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0888-2025
• Recall Event ID: 96079
• 510(K)Number: K022960
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
• Code Information: 1) 5178728: UDI/DI N/A, System ID YN1200, Serial Number: 16179; System ID YN1650, Serial Number: 17339. 2) H3000WE: UDI/DI N/A, System ID 82426060010, Serial Number Not Available; System ID 82426080021, Serial Number Not Available; System ID 82426090035, Serial Number 18605; System ID 82426090037, Serial Number 18604; System ID 82426100057, Serial Number 19191; System ID 82426150036, Serial Number 18624; System ID 82426150038, Serial Number Not Available; System ID 82426180015, Serial Number 18611; System ID 082426010021, Serial Number 18644; System ID 082426030032, Serial Number 18627; System ID 082426050012, Serial Number 18629; System ID 082426070041, Serial Number 18639; System ID 082426090044, Serial Number 18652; System ID 082426100067, Serial Number 18648; System ID 082426100069, Serial Number 18641; System ID 082426120031, Serial Number 18656; System ID 082426120033, Serial Number 18650; System ID 082426140029, Serial Number 18628; System ID 082426140030, Serial Number 18647; System ID 082426150039, Serial Number 18651; System ID 082426150040, Serial Number 18657; System ID 082426160040, Serial Number 18442; System ID 082426160054, Serial Number 18645; System ID 082426170004, Serial Number 18649; System ID 082426190031, Serial Number 18646; System ID 082426210028, Serial Number 18655; System ID 082426230028, Serial Number 18653; System ID 082426250006, Serial Number 18637; System ID 671USNHINF, Serial Number 17799; System ID A5128757, Serial Number 17566. 3) H3000WM: UDI/DI N/A, System ID NM16353, Serial Number 16353; System ID YN1540, Serial Number 16335; System ID YN1555, Serial Number 16315. 4) H3000YG: UDI/DI N/A, System ID A5172908, Serial Number 16143.
• Recalling Firm/ Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; 4, Hayozma St; Tirat Carmel Israel
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer Reason for Recall: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
• FDA Determined Cause: Package design/selection
• Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/18/2024. The notice explained the safety issue and requested the following actions be taken: There are two populations potentially affected by this notification: NOTE: Specific serial numbers of the following affected systems: Infinia Nuclear Medicine Systems: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4; VG Nuclear Medicine systems: Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH; Brivo NM 615; Discovery NM 630; Discovery NM/CT 670, Discovery NM/CT 670 ES, Discovery NM/CT 670 DR, Discovery NM/CT 670 PRO, Discovery NM/CT 670 CZT; Optima NM/CT 640. For Serial Numbers listed in Appendix A of this letter: GE HealthCare requests that you STOP USING the system until GE HealthCare has inspected and if necessary, corrected your system and provided you with a letter indicating the system can be returned to clinical use. GE HealthCare has determined that these systems could have previously been transported or relocated without proper detector support. For Serial Numbers listed in Appendix B of this letter: You can continue to use your system, as GE HealthCare has determined that these systems have not previously been transported or relocated without proper detector support. For Serial Numbers listed in either Appendix A or Appendix B of this letter: GE HealthCare requests that you DO NOT physically relocate or transport your system from its current location. If you need to move or transport your system, please email GE HealthCare at recall.40910@gehealthcare.com to receive specific instructions to follow before moving the system. When emailing this address, please provide the following information: " System serial number " Current system location " The reason for the move or transport, and subsequent destination Do not proceed with a physical relocation or transport of your system until you have received these instructions and taken the actions descri
• Quantity in Commerce: 36 units
• Distribution: Worldwide
• 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