The Recall Desk
HighFDA (Devices)·Z-0185-2015·Announced 2014-11-19

GE Healthcare Recalls Varicam and VG Hawkeye Nuclear Medicine Devices

GE Healthcare is recalling 478 nuclear medicine imaging devices because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

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: The recall involves a risk-of-harm product (falling equipment on a patient) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed injuries.

Plain-English summary

GE Healthcare, LLC is recalling 478 units of Varicam/VG and VG Hawkeye nuclear medicine imaging devices. The affected models include H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, and H2508PD. These devices are used for general nuclear medicine imaging procedures to detect radioisotope tracer uptake in the patient body.

The recall is being issued due to a potential safety issue where loose fasteners securing the camera to the gantry could cause a portion of the system to fall onto the patient during a scan. GE is updating the Preventative Maintenance procedure and schedule, and has added an additional Preventative Maintenance check for loose fasteners on these Nuclear Medicine systems.

The devices were distributed worldwide, including the United States (nationwide, including Guam, Puerto Rico, and DC) and numerous international countries. No specific instructions for consumers are provided in the source text, but the recall involves a manufacturer update to maintenance procedures.

The recalled product

Product
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tra
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Nuclear Medicine Imaging
Hazard
Affected units
478

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 6 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · falling object

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