FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
- Recall number
- Z-0522-2018
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
- Status
- Terminated
- Initiated
- 2017-11-01
- Posted
- not on file
- Terminated
- 2018-08-14
- Reason
- One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
- Root cause
- Vendor change control
- Action
- Philips Healthcare is notifying the affected users of this issue via this Customer Information Letter and correcting via Field Change Order FC088200514.
- Quantity
- 2
- Distribution
- One domestic and 1 foreign consignee ( Spain)
- Lot, serial or model codes
- Ingenuity TF PET/CT Model # 882442
- 510(k) numbers
- ["K052640"]
- 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