FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: 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.
- Recall number
- Z-1156-2014
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- 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.
- Status
- Terminated
- Initiated
- 2014-01-08
- Posted
- 2014-03-07
- Terminated
- 2015-01-21
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 732 units in the US
- Distribution
- Worldwide Distribution - USA Nationwide Distribution
- Lot, serial or model codes
- p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX
- 510(k) numbers
- ["K031760"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28