FDA Medical Device Recalls (openFDA)
Philips Medical Systems Sales & Service Region No. America: Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.
- Recall number
- Z-0370-05
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Product
- Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.
- Status
- Terminated
- Initiated
- 2004-12-01
- Posted
- 2004-12-24
- Terminated
- 2006-02-10
- Reason
- X-Ray system may fall downward and could possibly hit the patient.
- Root cause
- Other
- Action
- A notification was sent to all customers via certified mail, return receipt requested starting on December 1, 2004. Field Service Engineers will contact the customers to schedule a time for the column exchange starting mid-November and to be completed no later than Mid June 2005.
- Quantity
- 44 total units (Thoravision I and II)
- Distribution
- The firm distributed this product to hospitals and medical centers nationwide.
- Lot, serial or model codes
- See the site numbers listed for the Thoravision I. The listed site numbers include both Thoravision I and II products.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPR
- 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