The Recall Desk
HighFDA (Devices)·Z-1691-2016·Announced 2016-06-15

Sedecal Mobile X-ray System Recalled for Software Defect

Sedecal USA is recalling 145 mobile x-ray systems in the US due to a software defect that may apply adult exposure parameters to newborns.

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 risk-of-harm product (x-ray system) where injury has not yet been reported, fitting the High severity criteria for potential harm without confirmed incidents.

Plain-English summary

Sedecal USA, Inc. is recalling 145 Sedecal SA Mobile Diagnost w DR x-ray systems in the United States. The recall is due to a software defect in the Eleva User Interface.

The defect may cause the system to sporadically apply default x-ray exposure parameters for an adult (patient type: Normal) even when the patient type "Newborn" is selected and displayed. This issue affects systems distributed across 30 states, including Texas, Ohio, New York, and California.

Healthcare providers should contact Sedecal USA for instructions on how to resolve the software defect. The recall number is Z-1691-2016.

The recalled product

Product
Sedecal SA Mobile Diagnost w DR x-ray system
Manufacturer
Sedecal USA, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
145

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)

  • System Code 712001

Distribution

Distributed in 30 states:

Related recalls

Same hazard · software defect

See all →