GE CARESCAPE Canvas Smart Display monitors may fail to restart after power loss
GE CARESCAPE Canvas Smart Display monitors may fail to turn on after a power loss, particularly following battery replacement, potentially delaying recognition of patient condition changes.
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: This FDA Class II recall involves a device failure with no reported injuries or illnesses to date. However, the malfunction affects a critical patient monitoring device, and loss of monitoring capability could delay recognition of patient condition changes, representing a potential risk of patient harm.
Plain-English summary
GE Healthcare has issued a recall for CARESCAPE Canvas physiological monitors including the Canvas 1000, Canvas Smart Display, and certain versions of B850 and B650 models due to a potential power-on failure. Following replacement of the CPU timekeeper battery, if a loss of mains power occurs during active monitoring, the affected displays may not turn on after power is restored.
This malfunction could delay recognition of changes in patient condition until a replacement monitor is connected. The issue is described as unlikely but represents a potential risk to patient safety in critical monitoring applications.
The recalled product
- Product
- CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Patient Monitor
- Hazard
- loss-of-monitoring
- power-on-failure
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)
- GTIN 00195278522313: a) 5700023
- Serial Numbers: 2534526-3-1
- 2553213-5-1
- 2606854-2-1
- 5220256-1-1
- 5215673-1-1
- 5215634-1-1
- 5264236-1-1
- 5264113-1-1
- 5245953-1-1
- 5264089-1-1
- 5275734-1-1
- 5301535-1-1
- 5300969-1-1
- 5341313-1-1
- 5395275-1-1
- 5232613-1-1
- 5232595-1-1
- 5287222-1-1
- 5390098-3-1
Distribution
Distribution scope not specified by the agency.
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