FDA Medical Device Recalls (openFDA)
Datascope Corp: Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
- Recall number
- Z-1104-05
- Recalling firm
- Datascope Corp
- Product
- Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
- Status
- Terminated
- Initiated
- 2005-06-16
- Posted
- 2005-08-06
- Terminated
- 2005-10-05
- Reason
- Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.
- Root cause
- Other
- Action
- The firm sent a field correction communications to all customers via certified mail on 6/10/2005. A Datascope Service Representative will conduct and document this corrective action during a visit to the customer.
- Quantity
- 70 units
- Distribution
- There were 68 domestic customers nationwide and 2 international customers in Belgium and Italy.
- Lot, serial or model codes
- All units currently out in the market.
- 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