FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional, universal X~ray system with remote controlled facilities. Routine examinations that can be performed with the Diagnost include: Gastro-Intestinal examination, Urograpy, Bronchography, Arthrography, Hysterography, Myelography, Lymphography, Skeletal radiography, Tomography and Venography/phlebography. Special procedures that require subtracted and non subtracted digital imaging include: Angiography, Peripheral angiography (bolus chasing) and Vascular and non~vascular interventional procedures
- Recall number
- Z-2765-2011
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional, universal X~ray system with remote controlled facilities. Routine examinations that can be performed with the Diagnost include: Gastro-Intestinal examination, Urograpy, Bronchography, Arthrography, Hysterography, Myelography, Lymphography, Skeletal radiography, Tomography and Venography/phlebography. Special procedures that require subtracted and non subtracted digital imaging include: Angiography, Peripheral angiography (bolus chasing) and Vascular and non~vascular interventional procedures
- Status
- Terminated
- Initiated
- 2011-04-18
- Posted
- 2011-07-08
- Terminated
- 2013-02-15
- Reason
- Updated Instructions For Use: During an examination where the patient is positioned on a -rotatable- chair with knees pointed to the rear of the system, the patients lower legs or ankles may be injured/broken
- Root cause
- Device Design
- Action
- Philips Healthcare notified accounts by letter on April 18, 2011. The letter advised users of the problem and provided updated instructions for proper placement of the patient during the examination. An Updated Instruction For Use was provided. For further information and support customers were instructed to contact the Philips representative.
- Quantity
- 52 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K912470"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- 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