The Recall Desk
HighFDA (Devices)·Z-1781-2019·Announced 2019-06-19

GE Centricity PACS-IW Recall for Potential Missing Image Series

GE Healthcare is recalling 620 units of Centricity PACS-IW software because image series may be missing from exams without a warning.

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 involves a medical device where a defect could lead to missing diagnostic data, representing a risk of harm where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 620 units of GE Centricity PACS-IW software, versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10. The affected model numbers are 2052831-00x, 2050578-0xx, 2090228-002, and 2052782-00x. The units were distributed worldwide.

The recall is due to a potential defect where one or more image series may be missing from an exam without a warning displayed in the viewer. This could result in incomplete diagnostic information being available to healthcare providers.

Healthcare facilities using the affected software should contact GE Healthcare for further instructions on how to resolve the issue. No specific corrective action steps are detailed in the provided source text.

The recalled product

Product
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
620

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)

  • a) 2052831-00x

Distribution

Distribution scope not specified by the agency.

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