Class IIOngoingZ-0898-2025

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Infinia I Hawkeye 1

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGTirat Carmel, IsraelReported Jan 22, 2025 · 1 year ago

Legal News Analyst · Jan 22, 2025

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission

Lot / code information

Serial #: 16433. 2) H3000YM: UDI/DI N/A, System ID 602406INF
Serial #: 16012; UDI/DI N/A, System ID 928537INF
Serial #: 16021; UDI/DI N/A, System ID 661633NM1
Serial #: 15013; UDI/DI N/A, System ID 661633NM1
Serial #: 16051; UDI/DI N/A, System ID 619482INFINIA
Serial #: 16007; UDI/DI N/A, System ID 626359INF2
Serial #: 16175; UDI/DI N/A, System ID 626359INF1
Serial #: 16177; UDI/DI N/A, System ID 916983INFN1
Serial #: 16059; UDI/DI N/A, System ID 858554INF1
Serial #: 16169; UDI/DI N/A, System ID 858554INF2

What the firm is doing

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

DistributionShow details

Worldwide

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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