The Recall Desk
SevereFDA (Devices)·Z-2258-2020·Announced 2020-06-10

GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect

GE Healthcare is recalling 526 Nuclear Medicine systems because outdated software caused a patient's finger to be injured during an automatic unload process.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a reported injury to a patient (finger injury) and is classified as FDA Class II, which aligns with the 'Severe' criteria for significant injury reports.

Plain-English summary

GE Healthcare, LLC is recalling 526 units of the System, Tomography Computed Emmission (Nuclear Medicine systems). The recall is due to a software defect where the systems were operating without currently updated software. This issue was identified after a recent event in which a patient's finger was injured during the Unload process while the automatic Unload feature was being used.

The affected systems are distributed domestically across numerous US states and internationally in multiple countries. The specific models involved are ASM001605, H3000YT, H3000YW, H3000YY, and H3000ZW. The recall covers a specific list of serial numbers provided in the official notice.

Healthcare facilities should verify if their systems are affected by checking the model and serial numbers against the recall list. If a system is affected, it should be taken out of service until the software is updated to the current version to prevent further injuries.

The recalled product

Product
System, Tomography Computed Emmission
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Nuclear Medicine Systems
Hazard
Affected units
526

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)

  • Model for Ventry: ASM001605
  • H3000YT
  • H3000YW
  • H3000YY
  • H3000ZW Serial Numbers: 11075
  • 11430
  • 11137
  • 11154
  • 11138
  • 11512
  • 11322
  • 11093
  • 11301
  • 11286
  • 11294
  • 11021
  • 11078
  • 11125
  • 11235
  • 11387

Distribution

Distributed in 40 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

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Same hazard · mechanical injury

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