CLASS II Device recall · Reported 19 Mar 2014 · FDA Enforcement Report
Panaroma Central Station recalled by Mindray DS USA
Mindray DS USA is recalling Panaroma Central Station, distributed nationwide in the US. The recall was initiated on 8 Jan 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1156-2014
- FDA event ID
- 67495
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jan 2014
- FDA classified
- 7 Mar 2014
- Reported
- 19 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 8 Jan 2014 | Recall initiated by company | |
| 7 Mar 2014 | Classified by FDA | +58 days |
| 19 Mar 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray¿s V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
Where it was distributed
Worldwide Distribution - USA Nationwide Distribution
Questions about this recall
Is Panaroma Central Station recalled?
Yes. Mindray DS USA recalled Panaroma Central Station on 8 Jan 2014. The recall is Class II and its status is Terminated. Recall number Z-1156-2014.
Why was it recalled?
Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray¿s V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.
Which lots are affected?
p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX
Where was it sold?
Worldwide Distribution - USA Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mindray DS USA
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hardware configuration of the BeneVision Central Monitoring recalled | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer to recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer to recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | BeneVision N1 Patient Monitor (N1) recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS II | Sevoflurane E_Vap.(Quik-Fil):used recalled by Mindray DS USA | Mindray DS USA | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |