FDA Medical Device Recalls (openFDA)
Spacelabs Medical Inc.: Ultraview 1700 Monitor Model 90387.
- Recall number
- Z-1008-04
- Recalling firm
- Spacelabs Medical Inc.
- Product
- Ultraview 1700 Monitor Model 90387.
- Status
- Terminated
- Initiated
- 2004-05-07
- Posted
- 2004-07-20
- Terminated
- 2006-04-08
- Reason
- Potential for telemetry channels to drop off display.
- Root cause
- Other
- Action
- For all US customers, a Medical Device Correction letter was mailed on May 7, 2004 via courier instructing their customers to insure all monitored patients are displayed. The letter also instructed customers to move the printer to another central monitor as well as having a Field Service Engineer install new software when it becomes available. This letter was also mailed to international customers on May 14, 2004.
- Quantity
- 1650 units
- Distribution
- The firm distributes to hospitals nationwide. The firm also distributes to distributors internationally.
- Lot, serial or model codes
- Serial numbers 387-1xxxxx or higher
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DSI
- Firm FEI
- 3010157426
- Firm city
- Issaquah
- Firm state
- WA
- 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