Reported Jan 22, 2025 · Ongoing
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC;…
Ge Medical Systems Israel, Functional Imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · 4, Hayozma St · Tirat Carmel · N/A
Is this the product you have?
- GE Healthcare Infinia II Hawkeye 4
- Model/Catalog Numbers
1) H2799PP2) H2799PR3) H2799YC4) H2799YD5) H3000WC6) H3000WD7) H3000WT8) H3000WW9) H3000WY10) H3000WZSystemTomographyComputedEmission
- Lot codes and dates
585 of 585 products
Products covered by this recall # Barcodes Product as published 1 UDI/DI N/A, System ID 850260060, Serial Number 16130. 2) H2799PR: UDI/DI N/A, System ID 217347INF2, Serial Number 17325. 3) H2799YC: UDI/DI N/A, System ID M54606103, Serial Number 16846. 4) H2799YD: UDI/DI N/A, System ID M348992912, Serial Number 17033. 5) H3000WC: UDI/DI N/A, System ID 907562HK4, Serial Number 18610 2 UDI/DI N/A, System ID 907562HK4, Serial Number 18643 3 UDI/DI N/A, System ID 205783INF1, Serial Number 17571 4 UDI/DI N/A, System ID 479553INF, Serial Number 18470 5 UDI/DI N/A, System ID 479441INF1, Serial Number 17301 6 UDI/DI N/A, System ID 928855INF, Serial Number 17190 7 UDI/DI N/A, System ID 480512INF1, Serial Number 17019 8 UDI/DI N/A, System ID 602406INF1, Serial Number 18422 9 UDI/DI N/A, System ID 602406INF3, Serial Number 18465 10 UDI/DI N/A, System ID 480323INFRM3, Serial Number 17488 11 UDI/DI N/A, System ID 480882INF1, Serial Number 18026 12 UDI/DI N/A, System ID 530888IN1, Serial Number 18579 13 UDI/DI N/A, System ID 760873NUC, Serial Number 17290 14 UDI/DI N/A, System ID 6502IN1, Serial Number 17680 15 UDI/DI N/A, System ID 916537IN2, Serial Number 17264 16 UDI/DI N/A, System ID 510537IN1, Serial Number 18280 17 UDI/DI N/A, System ID 626915INF1, Serial Number 16946 18 UDI/DI N/A, System ID 209223IN, Serial Number 18308 19 UDI/DI N/A, System ID 559353IN, Serial Number 17995 20 UDI/DI N/A, System ID 626573INF1, Serial Number 17410 - Amount recalled
- 845 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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