Carescape Software
Software V3.2
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Mehow Innovative Ltd | Shenzhen | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | BZL |
| Device type | Computer, Oxygen-Uptake |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1730 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213181 |
| Record published | 2026-04-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MGC Diagnostics | Medical Graphics Corp. | 43 |
| Cosmed | C O S M E D SRL | 4 |
| Metaphor Flow Sensor | TreyMed, Inc. | 3 |
| Computer, Oxygen-Uptake | GE Healthcare Finland OY | 2 |
| MCG Diagnostics | Medical Graphics Corp. | 1 |
| Vista Mini-CPX Silver Edition | Vacumed | 1 |
| Maxii | AEI Technologies Inc. | 1 |
| MGC Diganostics | Medical Graphics Corp. | 1 |
| MAXIIa | AEI Technologies Inc. | 1 |
| Vista-MX Metabolic Measurement System | Vacumed | 1 |
| MGC Diagnsotics | Medical Graphics Corp. | 1 |
| MediPines Gas Exchange Monitor Starter Kit | Medipines Corporation | 1 |
Showing 12 of 22. All products under Computer, Oxygen-Uptake
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | 510(k) number | 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 3271 |
| GE Healthcare Finland OY | 510(k) number | 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 547 units |
| GE Healthcare Finland OY | 510(k) number | 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 54800 units |
| GE Healthcare Finland OY | 510(k) number | 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 25268 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.