FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.
- Recall number
- Z-0094-04
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.
- Status
- Terminated
- Initiated
- 2003-09-15
- Posted
- 2003-11-06
- Terminated
- 2008-10-29
- Reason
- Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.
- Root cause
- Other
- Action
- The firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units.
- Quantity
- 1,334 units installed
- Distribution
- The systems were installed at medical facilities located nationwide and worldwide.
- Lot, serial or model codes
- All serial numbers / all models.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- 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