The Recall Desk
HighFDA (Devices)·Z-0118-2014·Announced 2013-11-06

GE Centricity PACS-IW Software Recall for Patient Safety Risks

GE Healthcare is recalling Centricity PACS-IW software due to issues that could display incorrect patient images or under-report dose values, posing a safety risk to patients.

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 is classified as FDA Class II and involves a risk of harm (incorrect patient images and dose reporting) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

GE Healthcare is recalling the Centricity PACS-IW software system, which is used to receive, store, and display medical images including mammograms. The recall affects 847 units distributed worldwide, including in the United States and various international locations. The system is typically used by trained medical professionals such as physicians, radiologists, and nurses.

The recall was initiated because multiple issues were identified that could pose a safety risk to patients. Specifically, when the Auto-Fetch feature is in use, images from another patient may appear without the user's intention. Additionally, if the dose administration time and image acquisition time fall on either side of midnight, the dose value may be under-reported and close to zero for all pixels.

Healthcare facilities using the affected software versions (3.7.1 through 3.7.3.8) should contact GE Healthcare for instructions on how to resolve these issues. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks
Manufacturer
Ge Healthcare It
Category
Medical Device — Software
Hazard
Affected units
847

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 (10)

  • Software Versions: 3.7.1
  • 3.7.1.1
  • 3.7.2
  • 3.7.3.1
  • 3.7.3.3
  • 3.7.3.4
  • 3.7.3.5
  • 3.7.6.3
  • 3.7.3.7
  • and 3.7.3.8

Distribution

Distributed in 51 states:

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