731 Ventilator
Ventilator, Commercial, Zvent, MRI Conditional, Refurb
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Zoll Medical Corporation, United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2024-06-18 |
| Record revised | 2026-02-13 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature 0 to 0 °C; Storage environment atmospheric pressure from 0 KiloPascal; Storage environment temperature 0 to 0 °C; Storage environment humidity 0 to 0 % RH |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8660-001401-01-66 | In distribution | |
| 8660-001403-01-66 | In distribution | |
| 8660-001402-01-66 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233486 | 2024-12-13 |
| K162832 | 2017-08-02 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-04-30 | Class I | Under Investigation by firm | Operator’s Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure prope | 2361 units | |
| 2017-06-30 | Class II | Under Investigation by firm | A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings. | 46 | 2018-10-09 |
| 2012-03-19 | Class III | Process control | Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB. | Ten Units | 2012-08-15 |
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.