The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0773-2014·Announced 2014-01-22

GE Healthcare Recalls Imagecast PACS Software Due to Measurement Errors

GE Healthcare is recalling Imagecast PACS versions prior to 3.6.51.01 because the software fails to account for the estimated magnification factor, leading to inaccurate distance measurements.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves inaccurate measurement data rather than direct physical injury or a high-risk pathogen, fitting the criteria for a moderate severity software defect.

Plain-English summary

GE Healthcare is recalling Imagecast PACS versions prior to 3.6.51.01. The recall involves 43 units distributed nationwide across 23 states and the District of Columbia. Imagecast PACS is an image management system used by trained medical professionals to acquire, transmit, process, and store images and data in clinical environments.

The recall is due to a software defect where the estimated magnification factor (0018,1114) was not accounted for in versions prior to 3.6.51.01. The system relies on specific tags, such as Pixel Spacing (0020,0030) and Imager Pixel Spacing (0018,1164), to calculate measurements from pixels to millimeters. Because the estimated magnification factor is not used, the distance measurements generated by the software may be inaccurate.

This recall affects medical facilities using the affected software versions. Users should contact GE Healthcare for instructions on updating the software to version 3.6.51.01 or later to resolve the measurement calculation issue.

The recalled product

Product
Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data…
Manufacturer
Ge Healthcare It
Category
Medical Device — Software
Hazard
Affected units
43

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 (1)

  • Imagecast PACS versions prior to 3.6.51.01

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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