FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central viewing station. It is not intended to be directly connected to patient at any time or installed in a patient's vicinity.
- Recall number
- Z-0701-2016
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Product
- Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central viewing station. It is not intended to be directly connected to patient at any time or installed in a patient's vicinity.
- Status
- Terminated
- Initiated
- 2015-12-15
- Posted
- 2016-01-29
- Terminated
- 2017-03-29
- Reason
- An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations are maintained.
- Root cause
- Software design
- Action
- The firm, Mindray DS USA, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 12/15/2015 to its customers via certified mail. The letter described the product, problem, and actions to be taken. The customers were instructed to route the recall letter to all potential users of your facility. Mindray will resolve the issue by upgrading the system software on all affected Panorama systems in your facility. Please contact your Mindray Service Representative at 1-800-288-2121 (Monday-Friday 8:30am-5:30pm) to arrange upgrade. If you have any questions, please contact Director, Quality Operations and Regulatory Affair at 201-995-8407 or email to: d.arpino@mindray.com.
- Quantity
- 63 products
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- version 11.5.1
- 510(k) numbers
- ["K150082"]
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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