GE Healthcare Recalls Prestilix 1600X Digital Radiology Systems
GE Healthcare is recalling 825 Prestilix 1600X digital radiology systems because a monitor fell off its wall mount due to product aging.
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 involves a risk-of-harm product (falling equipment) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling 825 units of the Prestilix 1600X digital radiology system. The Prestilix system is a fully integrated remote controlled digital radiology system designed for general radiology applications and interventional procedures.
The recall was initiated after a reported incident where a Distar CRT monitor fell off its monitor wall mount. The source text attributes this incident to product aging.
The affected units were distributed worldwide, including in the United States and numerous international countries. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
- Manufacturer
- GE Healthcare, LLC
- 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 (20)
- 010120RX03
- 030024RX09
- 030047RX02
- 030077RX01
- 030083RX09
- 030106RX09
- 030236RX01
- 030259RX02
- 030557RX01
- 040059RX04
- 040092RX01
- 040200RX04
- 0779
- 080083RX11
- 110018RX01
- 12916PREST
- 130015RX03
- 130136RX01
- 130156RX01
- 13517PREST
Distribution
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.
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