Agency classClass IIOur severity:Severe FDA (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GE Healthcare is recalling 526 Nuclear Medicine systems because outdated software caused a patient's finger to be injured during an automatic unload process.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: mechanical-injury
software-defect
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 →

Same manufacturer · GE Healthcare, LLC

See all →

High
GE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
High
GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
High
GE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
High
GE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
Severe
GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27

Same hazard · mechanical injury