GE CARESCAPE Canvas monitors may lose display following power loss events
GE Healthcare medical monitors may fail to display following a power loss event after CPU battery replacement, potentially delaying patient condition recognition.
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: This is a Class II recall with no reported illnesses or injuries. The hazard (loss of monitoring and delayed patient condition recognition) constitutes a risk-of-harm scenario. Per the rubric: 'risk-of-harm products where injury has not yet been reported' receive a High (3) rating.
Plain-English summary
GE Healthcare is recalling CARESCAPE Canvas 1000 monitors and related display models due to a potential monitoring loss that can occur after CPU timekeeper battery replacement. If a mains power loss happens during active monitoring after such battery service, the affected monitors may fail to turn on when power is restored.
This failure prevents clinical staff from viewing patient vital signs and other monitoring information on the affected displays. According to the manufacturer, the loss of monitor display can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
The recall affects approximately 9,267 units distributed worldwide. The affected models are used in healthcare facilities for continuous patient monitoring.
Affected facilities should contact GE Healthcare regarding the recall for guidance on service, repair, or replacement of affected units.
The recalled product
- Product
- CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) 5865770-01055270; k) 5865770-01055317; l)…
- Manufacturer
- GE Healthcare Finland Oy
- Affected units
- 9,267
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 00195278522320: a) 5865770
- Serial Numbers: STN22230004HA
- STN22390002HA
- STN22390006HA
- STN22390007HA
- STN22520051HA
- STN23170167HA
- STN23290382HA
- STN23500120HA
- STN24030033HA
- STN24050016HA
- STN23270003SA
- STN24100007SA
- b) 5865770-01040169
- Serial Numbers: STN22230005HA
- STN22230010HA
- STN22230020HA
- STN22230023HA
- STN22230024HA
- c) 5865770-01054142
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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