FDA Medical Device Recalls (openFDA)
Datascope Corp: Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
- Recall number
- Z-0437-06
- Recalling firm
- Datascope Corp
- Product
- Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
- Status
- Terminated
- Initiated
- 2005-12-07
- Posted
- 2006-01-24
- Terminated
- 2006-08-01
- Reason
- Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
- Root cause
- Other
- Action
- Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer.
- Quantity
- 110 sites
- Distribution
- The product was distributed to hospitals and clinics nationwide. There is one US Government account, VA Medical Center, Birmingham, AL.
- Lot, serial or model codes
- All Panorama Central Station containing software versions 8.1.6 - 8.2
- 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
- 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