FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
- Recall number
- Z-1682-2015
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
- Status
- Terminated
- Initiated
- 2015-03-11
- Posted
- 2015-05-28
- Terminated
- 2018-06-26
- Reason
- It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data.
- Root cause
- Software in the Use Environment
- Action
- On 3/11/2015 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected device, explained the reason for the recall, how to identify affected product, advice on actions to be taken by customer/user, and any actions planned by the firm. Customers were advised to use software provided by Philips to view spectroscopy images; and, not to export and view images using third party software. The firm stated that it will be issuing a software update. If further information or support concerning the issue is needed, customers are asked to contact their local Philips representative or local Philips Healthcare office.
- Quantity
- 10 units
- Distribution
- Worldwide Distribution -- US, including the states of NY, OH, & TX; and, the countries of Finland, Germany, Japan, Netherlands, South Korea, Spain, & Switzerland.
- Lot, serial or model codes
- Serial #'s: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
- 510(k) numbers
- ["K103483"]
- 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