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Mindray DS USA, Inc. dba Mindray North America FDA Recalls
10 recalls on file across devices, 0 of them Class I and 9 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring Class IINov 18, 2025When the Worstation of the BeneVision DMS has a specific har |
| Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (SaClass IIOct 20, 2025Potential for anesthesia leakage. |
| Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (SClass IIOct 20, 2025Potential for anesthesia leakage. |
| BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00Class IIAug 15, 2025Potential for activation of an abnormal alarm pause. |
| Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with coClass IIJul 22, 2024V90 electronic vaporizer anesthetic agent output may be high |
| Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anestheticClass IIJul 22, 2024V90 electronic vaporizer anesthetic agent output may be high |
| Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with cClass IIJul 22, 2024V90 electronic vaporizer anesthetic agent output may be high |
| Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anestheticClass IIJul 22, 2024V90 electronic vaporizer anesthetic agent output may be high |
| 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-06004Class IIIMay 27, 2021Telepack may not power on when using the 3AA battery cradle. |
| Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 wheClass IIFeb 22, 2021BeneVision DMS may intermittently freeze and require a manua |