Patient Monitors May Fail to Display Vitals After Power Loss
GE Healthcare is recalling certain CARESCAPE Canvas patient monitors that may fail to display vital signs after a power loss if the CPU battery has been replaced. This could delay recognition of changes in patient condition.
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: FDA Class II recall of a critical patient monitor where the failure mode (inability to display vital signs) could delay recognition of patient deterioration. Although no illnesses or injuries have been reported, the hazard presents a risk of harm in a high-consequence medical device setting.
Plain-English summary
GE Healthcare is recalling 547 units of the CARESCAPE Canvas Smart Display patient monitor, which has worldwide distribution. Multiple model variants with specific serial numbers are affected.
The monitors have a potential loss-of-monitoring condition. If the CPU timekeeper battery is replaced and then a mains power loss occurs during active monitoring, the monitor may fail to turn on after power is restored. GE Healthcare characterizes this as an unlikely event.
This failure could delay recognition of changes in patient condition until a replacement monitor is connected. No injuries or illnesses related to this issue have been reported to date.
Healthcare facilities using the affected models should contact GE Healthcare for guidance. Customers should follow the manufacturer's instructions for identifying affected units and obtaining replacement or updated equipment.
The recalled product
- Product
- CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Patient Monitor
- Affected units
- 547
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) 5514418
- Serial Numbers: STZ22221001HA
- STZ22230001HA
- STZ22230002HA
- STZ22230003HA
- STZ22230004HA
- STZ22230006HA
- STZ22230007HA
- STZ22230008HA
- STZ22230009HA
- STZ22230010HA
- STZ22230011HA
- STZ22230013HA
- STZ22230014HA
- STZ22230017HA
- STZ22230018BP
- STZ22230019HA
- STZ22230020HA
- STZ22230021HA
- STZ22230022BP
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by GE Healthcare Finland Oy 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
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