The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2300-2016·Announced 2016-08-03

Ge Healthcare Recalls Imagecast PACS Software Due to Image Context Defect

Ge Healthcare is recalling Imagecast PACS software versions prior to 10.6 Update Package 18 because a defect causes images to be out of context with clinical information.

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 3/5 (High).

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 (medical imaging software) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed harm.

Plain-English summary

Ge Healthcare is recalling specific versions of its Imagecast PACS with Centricity RIS-IC software. The affected units are versions prior to 10.6 Update Package 18, including Imagecast PACS versions 3.5.69, 3.5.86, 3.5.87, and 3.6. The recall covers 13 units distributed nationwide in the United States.

The recall was initiated because a software defect was discovered that causes images to be out of context with clinical information. This system is intended for use by trained medical professionals to acquire, transmit, process, and store images and data in a clinical environment.

Healthcare facilities using the affected software should contact Ge Healthcare for instructions on how to resolve the defect. The source text does not report any specific injuries or illnesses associated with this software defect.

The recalled product

Product
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: 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…
Manufacturer
Ge Healthcare It
Category
Medical Device — Software
Hazard
Affected units
13

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 (3)

  • Imagecast PACS 3.5.69
  • 3.5.86
  • 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.

Distribution

Distributed nationwide across the United States.

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