FDA Medical Device Recalls (openFDA)
Philips Medical Systems Sales & Service Region No. America: Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
- Recall number
- Z-0369-05
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Product
- Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
- 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
- The firm uses site numbers instead of serial numbers. The listed site numbers include both Thoravision I and II products. 83956, 13253, 13917, 86223, 25709, 38975, 17579, 13610, 17506, 50321, 100322, 13919, 45032, 44803, 26294, 82617, 76802, 100633, 41354, 26058, 100693, 76806, X0212, 62971, 76374, 59408, 6960, 38715, 10405, 40932, 50319, 50320, 59670, 62972, 86451, X1068, 47101, 47167, 17620, 26214, 76020, 76021, 41437, 38989.
- 510(k) numbers
- ["K931071","K981657"]
- 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