FDA Medical Device Recalls (openFDA)
Philips Medical Systems Inc: Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.
- Recall number
- Z-0563-03
- Recalling firm
- Philips Medical Systems Inc
- Product
- Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.
- Status
- Terminated
- Initiated
- 2003-01-23
- Posted
- 2003-02-21
- Terminated
- 2008-10-29
- Reason
- The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.
- Root cause
- Other
- Action
- The firm mailed a ''Customer Advisory Notice'' to all affected customers on 1/23/2003.
- Quantity
- 311 units
- Distribution
- The sytems were shipped to end-users located nationwide and worldwide.
- Lot, serial or model codes
- All serial numbers of Models N210060 and N210335.
- 510(k) numbers
- ["K882312"]
- PMA numbers
- not on file
- Product code
- KPS
- 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