GE Healthcare CARESCAPE Monitor B650 — Class II medical device recall Z-2340-2018
Ongoing recall by GE Healthcare Finland Oy, reported 2018-07-11. When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for
| Recall number | Z-2340-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare Finland Oy, Helsinki, Finland |
| Recall initiated | 2018-05-25 |
| Classified | 2018-07-02 |
| Reported by FDA | 2018-07-11 |
| Quantity | 69,231 units |
| Serial numbers | SEW10354778HA, SEW11059204HA, SEW11059217HA, SEW11079353HA, SEW11079370HA, SEW11079373HA, SEW11079378HA, SEW11079394HA, SEW11079396HA, SEW11079419HA, SEW11079425HA, SEW11079436HA, SEW11079441HA, SEW11079463HA, SEW11079465HA, SEW11079466HA, SEW11079469HA, SEW11079479HA, SEW11079493HA, SEW11079496HA, SEW11079507HA, SEW11079509HA, SEW11079511HA, SEW11079512HA, SEW11079526HA and 475 more |
Product
GE Healthcare CARESCAPE Monitor B650
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2340-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.