Mindray Recalls Panorama Patient Monitoring Network Due to Software Anomaly
Mindray is recalling four Panorama Patient Monitoring Network units due to a software anomaly that prevents arrhythmia alarms from displaying on the Panorama system after a restart.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a failure to display critical arrhythmia alarms in a medical device, which poses a risk of harm to patients even though no specific injuries are reported in the source text.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling four units of the Panorama Patient Monitoring Network, Multi-Parameter Patient Monitor (Part number 0998-00-0708-01, Software version 8.9). The recall is due to a software anomaly that occurs when the Panorama system is used with the Mindray Passport V Monitor.
The specific issue involves arrhythmia alarms that were previously displayed on both the Passport V and Panorama systems. Following a restart of either system—whether due to communication loss or other reasons—these alarms will no longer be displayed on the Panorama system. This defect affects the ability of the Panorama system to display specific alarm information after a system restart.
The affected units were distributed worldwide and nationwide in the United States, specifically within the state of Texas. Healthcare facilities and users of this equipment should contact Mindray for instructions on how to resolve the software issue.
The recalled product
- Product
- Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients…
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient Monitor
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part No: 0998-00-0708-01 Software version 8.9
Distribution
Related recalls
Same manufacturer · Mindray DS USA, Inc. dba Mindray North America
See all →- HighCentral monitoring workstations recalled over audio failure and screen freezing
FDA (Devices) · 2025-12-24
- HighAnesthesia vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighIsoflurane vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighPatient monitors recalled over potential activation of an abnormal alarm pause
FDA (Devices) · 2025-10-01
- HighSevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction
FDA (Devices) · 2024-09-11
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighMindray Recalls Panorama Patient Monitoring Network Software Due to Restart Issue
FDA (Devices) · 2016-02-10
- ModerateMindray Panorama Patient Monitoring Network Recalled for Date Reversion
FDA (Devices) · 2016-05-04
- ModerateMindray Recalls Panorama Central Station for Time Clock Data Lag
FDA (Devices) · 2014-03-19
- HighMindray DPM Central Monitoring System Recalled for ECG Waveform Anomaly
FDA (Devices) · 2013-02-20
- HighMindray Recalls DPM5 Monitors Due to Missing ST and Arrhythmia Features
FDA (Devices) · 2013-02-06
- ModerateMindray DPM 7 Patient Monitors Recalled for Black Screen Display
FDA (Devices) · 2015-09-16