Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical
FDA device recall Z-1156-2014 · posted 2014-03-07 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- 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 Mindrays 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.
- Action taken
- Mindray DS USA Inc. sent an Urgent Corrective Action letter dated January 8, 2014 via certified mail to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact Mindray Service Representative, at 1-800-288-2121 (Monday Friday 8:30 am-5:30 pm), to arrange for the software update of the Panorama System(s) in their facility. This work will be performed at no cost.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 732 units in the US
- Distribution
- Worldwide Distribution - USA Nationwide Distribution
- Date initiated
- 2014-01-08
- Date posted
- 2014-03-07
- Date terminated
- 2015-01-21
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIEWPOINT TELEMETRY SYSTEM (K031760) | Datascope Corp. | 2003-10-10 |