| | Class 2 Device Recall GE Healthcare Infinia |  |
| Date Initiated by Firm | December 18, 2024 |
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| Date Posted | January 10, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0898-2025 |
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| Recall Event ID |
96079 |
| 510(K)Number | K022960 |
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| Product Classification |
System, tomography, computed, emission - Product Code KPS
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| Product | GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers:
1) H3000WN;
2) H3000YM;
3) H3000YS; System, Tomography, Computed, Emission |
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| Code Information |
1) H3000WN: UDI/DI N/A, System ID YN1593, Serial Number 16433.
2) H3000YM: UDI/DI N/A, System ID 602406INF, Serial Number 16012; UDI/DI N/A, System ID 928537INF, Serial Number 16021; UDI/DI N/A, System ID 661633NM1, Serial Number 15013; UDI/DI N/A, System ID 661633NM1, Serial Number 16051; UDI/DI N/A, System ID 619482INFINIA, Serial Number 16007; UDI/DI N/A, System ID 626359INF2, Serial Number 16175; UDI/DI N/A, System ID 626359INF1, Serial Number 16177; UDI/DI N/A, System ID 916983INFN1, Serial Number 16059; UDI/DI N/A, System ID 858554INF1, Serial Number 16169; UDI/DI N/A, System ID 858554INF2, Serial Number 16186; UDI/DI N/A, System ID 626570INF1, Serial Number 16030; UDI/DI N/A, System ID 310543INF1, Serial Number 16006; UDI/DI N/A, System ID 303320IH, Serial Number 16013; UDI/DI N/A, System ID 860350INIF, Serial Number 16065; UDI/DI N/A, System ID 863687INF1, Serial Number 16182; UDI/DI N/A, System ID 941629INF, Serial Number 16026; UDI/DI N/A, System ID 630801INF, Serial Number 16054; UDI/DI N/A, System ID 316962WI, Serial Number 16048; UDI/DI N/A, System ID 270651INF1, Serial Number 16002; UDI/DI N/A, System ID 225765INF1, Serial Number 16070; UDI/DI N/A, System ID 318681INFINIA, Serial Number 16033; UDI/DI N/A, System ID 508828INF, Serial Number 16173; UDI/DI N/A, System ID 906776INF, Serial Number 16001; UDI/DI N/A, System ID 989723INF1, Serial Number 16050; UDI/DI N/A, System ID 989723INF2, Serial Number 16073; UDI/DI N/A, System ID 919934INF, Serial Number 16099; UDI/DI N/A, System ID 603650INFINIA1, Serial Number 16151; UDI/DI N/A, System ID 973625INFINIA, Serial Number 16083; UDI/DI N/A, System ID 716366INF, Serial Number 16123; UDI/DI N/A, System ID 516570INF, Serial Number 16082; UDI/DI N/A, System ID 518828INF, Serial Number 16084; UDI/DI N/A, System ID 516622INFINIA, Serial Number 16167; UDI/DI N/A, System ID 585922INF1, Serial Number 16155; UDI/DI N/A, System ID 845987INFINIA, Serial Number 16091; UDI/DI N/A, System ID 937208INF1, Serial Number 16159; UDI/DI N/A, System ID 405271IH1, Serial Number 16011; UDI/DI N/A, System ID 814362INFINIA, Serial Number 16171; UDI/DI N/A, System ID 717782INF, Serial Number 16015; UDI/DI N/A, System ID 717627INFINIA, Serial Number 16166; UDI/DI N/A, System ID 605333INFINIA, Serial Number 16010; UDI/DI N/A, System ID 605333INFINIA, Serial Number 15007; UDI/DI N/A, System ID 615322NM3, Serial Number 16163; UDI/DI N/A, System ID 615768SCNM1, Serial Number 16005; UDI/DI N/A, System ID 713785SLINF1, Serial Number 16037; UDI/DI N/A, System ID 210921NM1, Serial Number 16043; UDI/DI N/A, System ID 434924INF2, Serial Number 16009; UDI/DI N/A, System ID 434924INF1, Serial Number 16028; UDI/DI N/A, System ID LGMCINF2, Serial Number 16038; UDI/DI N/A, System ID 206223INF, Serial Number 16052; UDI/DI N/A, System ID 509474INFINIA, Serial Number 16008; UDI/DI N/A, System ID 608263INF, Serial Number 16064; UDI/DI N/A, System ID 920684INF, Serial Number 16109; UDI/DI N/A, System ID 414384INF, Serial Number 16081; UDI/DI N/A, System ID 0910266042, Serial Number 16087; UDI/DI N/A, System ID 030232NU07, Serial Number 16003; UDI/DI N/A, System ID 110034NU04, Serial Number 16140; UDI/DI N/A, System ID 130139NU02, Serial Number 15006; UDI/DI N/A, System ID 604278INFINIA1, Serial Number 16153; UDI/DI N/A, System ID 604875INFINIA2H, Serial Number 16154; UDI/DI N/A, System ID 519752INFINIA, Serial Number 16027; UDI/DI N/A, System ID 905372INFINIA, Serial Number 16022; UDI/DI N/A, System ID 519749INFINIA, Serial Number 16044; UDI/DI N/A, System ID 416756INFINIA, Serial Number 16107; UDI/DI N/A, System ID 905731INFINIA, Serial Number 16039; UDI/DI N/A, System ID 819563CINFINIA, Serial Number 16063; UDI/DI N/A, System ID 450654INF1, Serial Number 16060; UDI/DI N/A, System ID 082426200003, Serial Number 16024; UDI/DI N/A, System ID 082426090016, Serial Number 16138; UDI/DI N/A, System ID 082426160026, Serial Number 16172; UDI/DI N/A, System ID S4160059, Serial Number 16114; UDI/DI N/A, System ID 783348NU01, Serial Number 16079; UDI/DI N/A, System ID 83026602101643, Serial Number 16126; UDI/DI N/A, System ID A107840402, Serial Number 16016; UDI/DI N/A, System ID A5109126, Serial Number 16148; UDI/DI N/A, System ID A5197927, Serial Number 16142; UDI/DI N/A, System ID MA1154NM02, Serial Number 16019; UDI/DI N/A, System ID 85150299222, Serial Number 16031; UDI/DI N/A, System ID 0843260032, Serial Number 16178; UDI/DI N/A, System ID ZA2876NM01, Serial Number 16032; UDI/DI N/A, System ID 0856260023, Serial Number 16057; UDI/DI N/A, System ID 45001NUC01, Serial Number 16049; UDI/DI N/A, System ID UK1063MR01, Serial Number 16150; UDI/DI N/A, System ID 00130NUC03, Serial Number 16164; UDI/DI N/A, System ID 01243NUC02, Serial Number 16127; UDI/DI N/A, System ID 01367NUC01, Serial Number 16132; UDI/DI N/A, System ID 00253NUC02, Serial Number 16137; UDI/DI N/A, System ID 00216NUC11, Serial Number 16004.
3) H3000YS: UDI/DI N/A, System ID 801562JVH02, Serial Number 16168; UDI/DI N/A, System ID 519749INFINIA2, Serial Number 16074; UDI/DI N/A, System ID 82426130041, Serial Number 16134; UDI/DI N/A, System ID DK1029NM05, Serial Number 16158; UDI/DI N/A, System ID A5152964, Serial Number 16141. |
Recalling Firm/
Manufacturer |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
4, Hayozma St
Tirat Carmel Israel
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| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
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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. |
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FDA Determined
Cause 2 | Package design/selection |
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| 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 |
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| Quantity in Commerce | 93 units |
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| Distribution | Worldwide |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = KPS
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