The Recall Desk
HighFDA (Devices)·Z-1755-2019·Announced 2019-06-19

GE Healthcare Recalls Silhouette VR Systems Due to Monitor Mount Failure

GE Healthcare is recalling 825 Silhouette VR systems because a CRT monitor fell off its wall mount due to product aging.

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 (falling monitor) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 825 units of the Silhouette VR system. The recall was initiated after a reported incident where a Distar CRT monitor fell off its monitor wall mount. The company attributes the failure to product aging.

The affected units were distributed worldwide, including in the United States and numerous international countries. The specific product codes associated with this recall are DZ1061RX02 and UP389014.

Healthcare facilities and consumers should contact GE Healthcare for instructions on how to address the potential safety hazard associated with the monitor wall mount.

The recalled product

Product
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard

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)

  • DZ1061RX02 and UP389014.

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · falling object

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