Agency classClass IIOur severity:High FDA (Devices)·Z-1078-2014·Announced 2014-03-05

GE Healthcare Wireless Digital Radiography Software Recall for Patient Safety

GE Healthcare is recalling Wireless Digital Radiography Option (WDR1) software due to a defect that may cause patient exams to display incorrectly, potentially impacting patient safety.

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 is classified as FDA Class II, and the source text explicitly states the issue 'may impact patient safety' without reporting specific injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling the Wireless Digital Radiography Option (WDR1) software used with Precision 500D and Proteus XR/a systems. The recall is due to a software issue associated with patient selection from the worklist that may impact patient safety.

The defect causes patient exams to be displayed improperly on the WDR1 intermittently when a large number of patient exams are retrieved from the HIS/RIS system. This issue affects 359 units, including 333 in the United States and 26 outside the US. The devices are distributed worldwide, including in the US, Argentina, Australia, Canada, France, Ireland, Italy, Jordan, Romania, Russia, the United Arab Emirates, and the United Kingdom.

Healthcare facilities using these systems should contact GE Healthcare for further instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Radiography Software
Hazard: software-defect
patient-safety

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Same manufacturer · GE Healthcare, LLC

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