FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance iCT Computed Tomography X-ray system
- Recall number
- Z-1695-2015
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance iCT Computed Tomography X-ray system
- Status
- Terminated
- Initiated
- 2015-04-13
- Posted
- 2015-05-29
- Terminated
- 2015-10-01
- Reason
- A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
- Root cause
- Other
- Action
- Philips sent an Urgent - Field Safety Notice dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Healthcare is recommending to stop the use of your system until the X-ray tube mounting fasteners are replaced. In addition, a Philips Field Service Engineer (FSE) will service your system via a Mandatory Field Change Order (FCO 72800638). A Philips FSE will contact you to schedule this appointment. If you need any further information or support concerning this issue, please contact your local Philips representative or your local Philips Healthcare office. This notice has been submitted to the appropriate Regulatory Agency. Philips apologizes for any inconveniences this problem has caused your organization. For further questions please call (440) 483-7600.
- Quantity
- 2
- Distribution
- Internationally to the countries of China and Norway.
- Lot, serial or model codes
- Model# 728306; Serial #'s: 85019 & 85023.
- 510(k) numbers
- ["K060937"]
- PMA numbers
- not on file
- Product code
- JAK
- 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
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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