Mindray Recalls Panorama Central Station for Time Clock Data Lag
Mindray is recalling 732 Panorama Central Stations because Full Disclosure data and event indicators may lag behind the system time clock.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling 732 units of the Panorama Central Station in the United States. The device is used to view, store, print, graph, and trend patient clinical and demographic data, as well as to set independent alarm limits for data sent by bedside monitors.
The recall was initiated because Mindray identified two issues where data may lag behind the Panorama system time clock. Specifically, Full Disclosure data may lag when the Central Station is used with Mindray’s V-Series Monitor, and event indicators may lag when used with a Panorama Telepack.
The affected units are identified by part numbers 0998-00-0708-01, 0998-UC-0708-01, and 0020-00-0205-XXX. The recall covers units distributed nationwide in the US.
The recalled product
- Product
- 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.
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Hazard
- Affected units
- 732
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 (2)
- p/n 0998-00-0708-01
- 0998-UC-0708-01 and 0020-00-0205-XXX
Distribution
Distributed nationwide across the United States.
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