FDA Device recall Z-2340-2018
GE Healthcare CARESCAPE Monitor B650
- FDA Device
- Class II
- ongoing
- Published 2018-07-11
On 2018-07-11 the FDA classified a Class II recall of GE Healthcare CARESCAPE Monitor B650 by Ge Healthcare Finland Oy, citing when multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2340-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-05-25 |
| Published | 2018-07-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare Finland Oy |
| Distribution | n/a |
Product
GE Healthcare CARESCAPE Monitor B650
Reason
When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
Identifiers
| code_info | Serial Numbers: SEW13497373HA SEW13497374HA SEW13497375HA SEW13497376HA SEW13508068HA SEW12494591HA SEW14280294…Serial Numbers: SEW13497373HA SEW13497374HA SEW13497375HA SEW13497376HA SEW13508068HA SEW12494591HA SEW14280294HA SEW14280298HA SEW14289769HA SEW14289777HA SK416341018HA SK416341019HA SK416341026HA SEW12494422HA SEW12494425HA SEW12494435HA SEW12494584HA SEW12494585HA SEW12494592HA SEW12494593HA SEW12494596HA SEW12494598HA SEW12494619HA SEW12494621HA SEW12494622HA SEW12494625HA SEW12494626HA SEW12504918HA SEW12504923HA SEW12504940HA SEW12504942HA SEW12504944HA SEW12504954HA SEW14278996HA SEW14279002HA SEW14279003HA SEW14279005HA SK416061047HA SK416061048HA SK416061088HA SK416081102HA SK416461063HA SK416461092HA SEW13109786HA SEW12059577HA SEW12059583HA SEW12059587HA SEW12059589HA SEW12059592HA SEW12059593HA SEW12059594HA SEW12059596HA SEW12059597HA SEW12059598HA SEW12059599HA SEW12059601HA SEW13275956HA SEW13276028HA SEW13276029HA SEW13275967HA SEW13276066HA SEW13276073HA SEW13286164HA SEW13286175HA SEW13286183HA SK41549 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2340-2018%22
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