The Recall Desk
HighFDA (Devices)·Z-0899-2025·Announced 2025-01-22

GE Healthcare nuclear medicine systems recalled for detector support risk

GE Healthcare nuclear medicine systems including Infinia II Hawkeye 4 may have been transported without proper detector support, risking detector failure and serious injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving risk of serious bodily injury from detector fall. The source text does not report any actual injuries or hospitalizations; the hazard is theoretical but involves potential life-threatening harm.

Plain-English summary

GE Healthcare is recalling certain Infinia II Hawkeye 4 and related nuclear medicine and CT imaging systems (approximately 845 units distributed worldwide) because they may have been transported or relocated without proper detector support during shipment or installation.

When proper detector support is absent during transportation, excessive load can be applied to the detector mounting mechanisms. This can result in detector failure and fall, potentially leading to life-threatening bodily injury to operators or patients near the equipment.

The affected systems have been distributed worldwide. No injuries have been reported to date. Facility managers should verify that proper detector support procedures are followed whenever any affected system is transported, relocated, or reinstalled.

The recalled product

Product
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Nuclear medicine imaging system
Hazard
  • detector-fall
  • mounting-failure
  • improper-transport
  • serious-injury-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) H2799PP: 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
  • UDI/DI N/A
  • Serial Number 18643
  • System ID 205783INF1
  • Serial Number 17571
  • System ID 479553INF
  • Serial Number 18470
  • System ID 479441INF1
  • Serial Number 17301
  • System ID 928855INF

Distribution

Distribution scope not specified by the agency.

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