FDA Medical Device Recalls (openFDA)
Philips Medical Systems Sales & Service Region No. America: Xcelera R1.2 Cardiology image and information management solution software.
- Recall number
- Z-0640-05
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Product
- Xcelera R1.2 Cardiology image and information management solution software.
- Status
- Terminated
- Initiated
- 2004-12-21
- Posted
- 2005-03-18
- Terminated
- 2006-02-10
- Reason
- Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
- Root cause
- Other
- Action
- The firm notified hospitals via letter sent 12/21/2004 stating the service organization will perform onsite upgrades.
- Quantity
- 33
- Distribution
- Hospitals and medical centers throughout the US.
- Lot, serial or model codes
- Xcelera Software version R1.2
- 510(k) numbers
- ["K022788"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000524572
- Firm city
- Bothell
- 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