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FDA Medical Device Recalls (openFDA)

Datascope Corp: Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

Recall number
Z-1567-05
Recalling firm
Datascope Corp
Product
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
Status
Terminated
Initiated
2005-08-19
Posted
2005-09-21
Terminated
2006-06-21
Reason
The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
Root cause
Other
Action
A recall letter was sent to the consignees on 8/19/2005.
Quantity
115 units
Distribution
The affected software was distributed to 108 domestic sites and seven international sites. There are no sale of affected Panorama software to the US Govt.
Lot, serial or model codes
Part Number 0040-00-0366-20.
510(k) numbers
K031760
PMA numbers
not on file
Product code
DRT
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

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